GMO ACTIVISM: Comments til June 19th at USDA: SIOI. JPP18

GMO Activism: 3 Major Policy Measures by June 19th.

USDA Secretary Sonny, thank you for respecting our intelligence.

Liberal Academia, Big Pharma money and Corporate Food, Stop Insulting Our Intelligence.

Right now, USDA is taking public comment on the three transparent GMO Policy actions taken in government and they are:

Genetic Engineering  Labeling

Crop GMO Policy

Livestock GMO Policy

usdaSend Sonny a Tweet:

#GMO  Dear Sonny, Section 1 has your name on it:      https://janepublicproject.org/2017/06/03/gmo-activism-comments-taken-only-til-june-19th-sioi-jpp18/

 

 Section One: Labeling Policy 

Secretary Sonny is currently drafting the framework for all labeling of food.  Any food with any genetically engineered produced ingredients shall be included on the label. We’ll take it!

But he can’t stop there.

Dear Sonny,

Please devise and incorporate a colored bar indexing system or a codified contaminant identifiers label strip to indicate presence/ use of pesticides, herbicide, fumigation, soil contamination and identify ecocide level of seed stock/nursery stock.

An example would be the wheat industry.  Standard commercial agriculture practice includes some harvesters mass spray glyophosphate  prior to harvest to lay the wheat down and force it to go to seed.  We need to know this.  The population has developed conditions such  as “gluten intolerance”.  This condition may not be wheat allergy, it is now linked to glyophosphate intolerance.

Therefore, every package would have labeled ingredients, nutritional information as well as a graphic label indicating ecocide levels, because nothing can be trusted to be “generally regarded as safe”.

Unless all GMO can be legally outlawed, then disregard that!. Livestock Foodstuffs codified graphic label strips should also trickle down to consumer packaging, if they were fed a toxic GMO alfalfa, we want to know.

 To do less would be unconsented human experimentation which violates The Nuremberg Code.

We Rise,

We The People

 

Case In Point: Glyophosphate Pathways to Autoimmune Disease (Humans)

                                                              Coincides with

                        Colony Collapse Disorder (Entomology) due to Neonicotinoids

                         

 

Trend: Monsanto GMO seeds have increasingly escalated aluminum uptake through genetics annually since 2003 to keep pace with chemtrailing which was heavily used from 2010 when the Agenda 21 desired to speed up their depopulation program, through soil and water contamination, especially nanoparticle desiccants(aluminum) which we eat and livestock eats.  The seeds themselves grow ecocide crops and we deserve to know where this seed stock falls in terms of  poison levels.

gluten reports

Fractional chart above exposes a sliver of the GI cases reported; however, we know 20,000,000 million Americans are affected by it, with an additional 5,000,000 afflicted with celiac disease.

gluten reports_002

These are just hospital cases of chronic episodic celiac. If we were to continue listing graphs like this for lactose intolerance, fibromyalgia, lupus and over 200 other autoimmune diseases and conditions including shingles and more, every chart is the same.  It’s plain to see the direct correlation of pesticide/GMO with decline in health.

 

Upwards trends of autoimmune conditions coincide exactly with FDA approvals and widespread  use of  pesticides which are currently not labeled or identified, yet we are eating them..

bee

This directly correlates to FDA approval of various lethal pesticides in 2006 and expanding to a widespread practice. https://www.hsph.harvard.edu/news/press-releases/colony-collapse-disorder-pesticide/

Monarch Butterfly Decline  1,250,000(1999) down to less than 20,000 (2017)

monarch

A 2017 visit to the Monarch Grove in Morro Bay, CA revealed there are less than 20,000 roosting there in the winter migration habitat, down from a 1,250,000 in 1997.  Monarchs are extremely susceptible to pesticide, as they draw nectar from flora in roadside ditches which often grows at the edge of corn fields.

Other label housekeeping:

-Reform GRAS with an approved ingredient list (such as sea salt, baking soda)

-Prevent loopholes for benign descriptors like “natural”,

-Reclassify cannabis for edibles with codifiers for THC levels as it relates to edibles

Admit the chemtrails poisoned the planet and stop pretending they aren’t there.

-Reform Water source monitoring to outlaw fracked water for agriculture

-Publish decontamination methodologies for aluminum and all other heavy metals

 

 

Section Two : GMO  Crop Policy

bees

 

RIN: 0579-AE15       Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

GO TO: https://www.regulations.gov/document?D=APHIS-2015-0057-0001r

HIT COMMENTS and fill in the field.

Comments  related to desired use of crops (besides none 🙂

Dear Commissioners of the FDA:

Except for ethanol or other approved energy uses, We The People reject all GMO as foodstuffs on the grounds it caused irreversible damage to everything it touched. GMO  was an unconsented experiment  of the human race which is direct violation of  global law of the  Nuremberg Code.  We The People are now faced with a pollinator die off for crops we  want to grow,  escalating autoimmune conditions and diseases as well as irreversible damage to our air, soil and water.

The overwhelming evidence of the coexistence of pesticides, herbicides and GMO as an Agenda 21, Agenda 2030 strategy were designed to depopulate the human race, and we reject this ideology. At no time ever should nutrient depletion be sacrificed and any strains currently available that don’t match organics should be abolished permanently.

Multiple suppressed reports indicate when the full damage of GMO is taken into account on every level including nutritional value, cause/effect autoimmunities, soil depletion, organics far and away outpace GMO.  The only advantage GMO brought was to the Corporate Food titans who played weatherization futures on their own crops on the Chicago Mercantile Exchange  and profited from seed sales for which they also offered financing.

Add a Grower Beware Clause: prohibit civil suit by bottomless bank account Titans for “over fence” contamination.  Even when rotated, GMO depletes soil of life source nutrients.

Add a “Soil Report Card” to every GMO farmer.  Depletion of soil leaves dead soils. Devise a system of soil health and minimum standards to avoid dead soils.  Desiccating qualities of aluminum trapped within harvested corn stalks deplete soil when turned under. Force soil health and crop rotation to non GMO through a soil report card.

dead soils would be just as appropriate as penalizing sulfuric smokestack output.

Farmers have been hijacked and forced to adopt GMO at virtual financial gunpoint;however, we must persevere in taking our country back, from the ground up.

Trump must end chemtrails now. The premise upon which Corporate Food Titans laid waste to our air, soil and water vanished November 8, 2016.  Toxic commercial agriculture products  and practices do not serve the health, safety and welfare of  our citizens.

Stop insulting our intelligence.

We deserve better, our children deserve the best.

We are awake. We rise.

 

 

Section Three : Altered Genomic DNA in Animals

duck

Federal Register Number: 2017-00839

https://www.regulations.gov/document?D=FDA-2008-D-0394-0279

HIT COMMENTS and fill in the field.

Comments must be limited to Animal DNA, you are welcome to cut and paste this one.

Dear Commissioners of the FDA:

Improving animal husbandry practices through gene editing can be beneficial  in some instances, and should not be wholly disregarded, and only cautiously applied.  Gene editing  used within a species(cow to cow) for the purpose of improving it’s quality of life or quality of product would be an acceptable use of animal genetics, as it also may be a positive force in reduction of antibiotics.

An example would be genetically enhancing a breed of chicken with naturally small “chicken wings” to improve the meat quality of the wing with an heirloom chicken breed having naturally large wings would be acceptable.  The litmus test  is the variation desired (bigger chicken wings)already occurs naturally in the same species(of another chicken breed already possessing larger wings).

Parameters defining acceptable practices and breeding would need to be clearly defined, especially to avoid inbreeding.  Registries should be implemented for such livestock, as registries exist for natural  livestock to avoid similar issues.

An example is horse breed registries indicates the long gestation period of a horse would wisely be spent on a union of blood compatible same breed (Clydesdale) horses as to achieve a desired outcome of a healthy foal.

Another example would be gene editing for better feathers of  a goose species possessing lofty down but is small bodied, to a larger bodied duck with shorter feathers.  More feathers fit on the larger bodied duck, and the cumulative effect on the consumer cost of down for pillows would be positively impacted by such a process.

Cross species mutagenesis is an aberration and should be banned from all experimental process, import and funding of any federal dollars.  Crossing cows with horses or goats with pigs renders no value and is simply experimental  for no worthwhile purpose.

Further, no mutagenesis or any gene editing shall ever be intended for an environment  of non-maternal live birth or “lab bag embryo development”.

Molecular editing tools such as CRISPR/Cas9 would be regulated as drugs as they should be, although a preapproved rare use would be the only use.  Cross generational negative effects can be a runaway problem with no easy solution and ultimately major destruction.   As in all cases, transparency at the consumer level is key.

The vast majority of consumers do not want a “tomato fish”, but wouldn’t mind fluffier pillows at reasonable prices.

We are awake to the simple fact food security is a key component of national security, because hunger and peace do not long coexist.  To restore trust, we must have transparency for choice.

We Rise

ACTIVATE: FLOTUS banned all Monsanto products at the WH. Let’s follow her lead, and make it Bayer too.

UPDATE:

This letter was submitted to the Comments for GMO FOOD 7 CFR part 340 by the American Farm Bureau Federation on June 19, 2017, the last day for comments. President of the American Farm Bureau Federation Skippy Duvall states on behalf of his members they are unhappy with the new USDA standards for testing and roll out of GMO food:

June 19, 2017
The Honorable Sonny Perdue
Secretary
United States Department of Agriculture
Jamie L. Whitten Federal Building
1400 Independence Avenue SW
Washington, DC 20250
Re: Proposed revisions to USDA agricultural biotechnology regulations (7 CFR part 340), Evaluation of Existing Regulations; Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, Docket No. APHIS-2015-0057
Dear Secretary Perdue:
We, the undersigned organizations, are pleased to submit these comments in response to the United States Department of Agriculture’s (USDA) request for public input on the proposed revisions to its biotechnology regulations (7 CFR part 340). Our member organizations represent a broad cross-section of stakeholders having a significant interest in the future of U.S. agriculture. In addition to the comments here, many of the organizations listed below intend to submit additional comments to the record reflecting the individual perspectives of our organizations.
Our organizations each have a major stake in the ability of U.S. growers to have access to products of cutting-edge technologies, as well as fostering continued public confidence in the U.S. regulatory system and in preserving U.S. access to international markets. Innovative plant and animal breeding methods hold enormous promise for improving the productivity and environmental sustainability of food, feed, fiber, horticulture, biofuels, health, and animal production. We are fully committed to engaging constructively with the USDA Animal and Plant Health Inspection Service (APHIS) to help the agency reach its regulatory goals, including development of a successful, broadly-supported system of regulation that provides risk-appropriate oversight consistent with the need for growers to have timely, reliable access to the products of innovative breeding techniques without disrupting access to markets.
We are supportive of USDA’s efforts to modernize its regulations, ensuring that they are up-to-date with the best-available science and utilize the more than 30 years of experience USDA has in reviewing the safety of these crops. We believe it is imperative USDA not only continues its important work to “right size” its oversight of agricultural biotechnology and other biology-based plant breeding innovations, but also provides strong leadership and vision to encourage other U.S. regulatory agencies as well as foreign governments to adopt consistent or compatible approaches.
The proposed revisions to USDA biotechnology regulations, published at the end of the previous administration, take some very positive steps in the right direction. USDA should be commended for making bold moves in proposing new regulations. The proposed revisions send clear, positive signals about the need to foster innovation by ensuring such regulatory oversight is proportional to actual risk— a message we strongly support. We also particularly appreciate the strong position USDA provided regarding the exclusion of products of newer breeding methods such as gene editing from the regulation based on the similarity of many products developed using these methods when compared to those developed using more traditional plant breeding methods.
Despite these positive aspects, regrettably, we believe that the regulatory system proposed by USDA has
significant shortcomings that could make it harder for USDA to meet its goals. The following shortcomings are
significant enough that we are unable to support the regulatory revisions as proposed:
 Researchers and developers cannot learn the regulatory status of new genetically engineered (GE)
organisms without undergoing complex and lengthy risk assessments, providing little transparency
and clarity about which products will actually be subject to regulation, and risking arbitrariness.
 Risk assessments would be conducted for plant products, merely based upon the technology used in
their production, regardless of the actual risk posed by the product. This runs counter to USDA’s 30+
years of experience regulating products of biotechnology.
 The proposed system shifts regulatory burden from commercialization stages to research and
development phases of product innovation. Each new GE plant variety will have to undergo complex
risk assessment and public comment before a single plant can even be planted in a small-scale field
trial.
 The proposed assessment process is unlikely to have the throughput capacity to accommodate the
scale of U.S. research and development, potentially leading many products to be trapped in regulatory
limbo while their regulatory status is being assessed.
 The proposed system would be a significant expansion of the authorities under Part 340, creating a
redundant weed risk regulatory process, which currently works under USDA’s Part 360 regulations.
The merging of the Part 360 authority into Part 340 would add significant complexity and raise
barriers to innovation. We urge USDA to maintain the distinction between these two authorities.
 The significant departure from the current regulatory system may have unintended consequences for
other regulatory agencies, and domestic and international markets, and lead to significant new
litigation risks.
We are concerned that these flaws will have a significant negative impact on innovation, particularly for small
companies and universities hoping to develop agricultural products for specific regional or environmental
needs or to develop minor use crops that could be important domestically and internationally. Ultimately, we
believe that problems with USDA’s proposed regulatory system are significant enough that USDA will need to
substantially revise the proposed rule in order to address them.
In the meantime, university and private plant breeders urgently need certainty regarding the regulatory status
of new varieties of plants developed using tools such as gene editing. USDA should use the rationale
described in the proposed rule for the exclusions to the definition of “genetically engineered organism” and
their responses to the “am I regulated” inquiries to make a clear policy statement on applications of gene
editing. Equally important, USDA should actively champion its proposed approach in ongoing international
discussions.
The new administration has an opportunity to refine the proposal laid out by the previous administration to set
a path forward for agricultural biotechnology and products derived from other precision breeding tools. We
believe USDA can better meet its goals with fewer risks and disruptions by charting a different regulatory
course, and we look forward to continuing to engage with USDA in its policy dialogue with a broad array of
stakeholders and interests to identify the best path forward.
Signed,
Agricultural Retailers Association
Alabama Farmers Federation
American Farm Bureau Federation
American Feed Industry Association
American Phytopathological Society
American Seed Trade Association
American Society of Plant Biologists
American Soybean Association
American Sugarbeet Growers Association
AmericanHort
Arizona Farm Bureau Federation
Arkansas Farm Bureau Federation
Arkansas Soybean Association
Association of Public and Land-grant Universities
Bio Nebraska Life Sciences Association
Biocom
BioNJ
Biotechnology Innovation Organization
California Association of Winegrape Growers
California Citrus Quality Council
California Farm Bureau Federation
California Life Sciences Association
California Specialty Crops Council
College of Agriculture and Natural Resources at the University of Delaware
Colorado BioScience Association
Colorado Farm Bureau
Crop Science Society of America
CropLife America
Florida Fertilizer & Agrichemical Association
Georgia Farm Bureau
H2 Research Innovation
Hawaii Crop Improvement Association
Hawaii Farm Bureau
Idaho Farm Bureau Federation
Idaho Potato Commission
Illinois Farm Bureau
Illinois Seed Trade Association, Inc.
Illinois Soybean Association
Indiana Farm Bureau
Indiana Seed Trade Association
Iowa Farm Bureau Federation
Iowa Seed Association
Iowa Soybean
Kansas Agribusiness Retailers Association
Kansas Cooperative Council
Kansas Farm Bureau
Kansas Grain and Feed Association
Kansas Wheat
Kentucky Farm Bureau Federation
Kentucky Life Sciences Council
Kentucky Soybean Association
Louisiana Farm Bureau Federation
Maryland Farm Bureau
Michigan Agri-Business Association
Michigan Biosciences Industry Association (MichBio)
Michigan Farm Bureau
Minnesota Crop Production Retailers
Minnesota Farm Bureau Federation
Mississippi Farm Bureau Federation
Missouri Biotechnology Association
Missouri Soybean Association
National Alliance of Independent Crop Consultants (NAICC)
National Association of State Departments of Agriculture
National Association of Wheat Growers
National Corn Growers Association
National Cotton Council
National Council of Farmer Cooperatives
National Potato Council
National Sorghum Producers
Nebraska Farm Bureau
Nebraska Soybean Association
New York Farm Bureau
New York State Agribusiness Association
Noble Research Institute, LLC
North Carolina Agribusiness Council, Inc.
North Carolina Farm Bureau
North Dakota Soybean Growers Association
North Dakota State University
Northern Seed Trade Association
Ohio AgriBusiness Association
Ohio Farm Bureau Federation
Oklahoma Farm Bureau
Oregon Farm Bureau
Oregonians for Food & Shelter
Pennsylvania Farm Bureau
Produce Marketing Association
Rural & Agriculture Council of America
Society of American Florists
South Dakota Biotech
South Dakota Farm Bureau
South Dakota Soybean Association
Southern Crop Production Association
Texas Citrus Mutual
United Fresh Produce Association
USA Rice
Utah Farm Bureau
Virginia Bio
Virginia Farm Bureau
Washington Farm Bureau
Washington State Potato Commission
Western Growers
Wisconsin Farm Bureau Federation
Wyoming Farm Bureau Federation

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­———————————————————————————————-

Contributing Sources

Bayer, Pioneer and Monsanto are Contributors to depopulation.

One use of this rice is dog food filler

Pioneer owns many patents as does Monsanto and the patents have become unsheathed swords as weaponized methods taking down small farmers whose crops and land they seized for “stealing” patented pollen via natural wind drift on all commodity crop products

Livestock eats this alfafa and then we eat the livestock, not so good.

 

 

How many people have Gluten Sensitivity, Celiac Disease?

By Jane Anderson – Reviewed by a board-certified physician.

Updated March 13, 2016

Excerpted

Dr. Fasano, director of the University of Maryland Center for Celiac Research, published the first study looking at the molecular basis for gluten sensitivity and how it differs from celiac disease. He also participated in the research concluding that celiac disease incidence is one in every 133 people.

According to Dr. Fasano, gluten sensitivity potentially affects far more people than celiac disease. He estimates about 6% to 7% of the U.S. population may be gluten-sensitive, meaning some 20 million people in the United States alone could have the condition.

Symptoms of gluten sensitivity in this population can include digestive problems, headaches, rashes and eczema-like skin symptoms, brain fog and fatigue, Dr. Fasano says. Almost one-third of those he’s diagnosed as gluten-sensitive report brain fog and headaches as symptoms, he says.

Drs. Ford, Fine Say Percentage Could Be Far Higher — Up To 50%

Dr. Ford, a pediatrician in Christchurch, New Zealand and author of The Gluten Syndrome, says he believes the percentage of people who are gluten-sensitive actually could be much higher — potentially between 30% and 50%.

Read the Full article: https://www.verywell.com/how-many-people-have-gluten-sensitivity-562965

We are awakened to the unconsented human experimentation by Bayer, Shell and Monsanto; therefore, we reject their products causing death and destruction including their GMO withand processes of seed patenting

We Rise.

Contributing Sources

 

http://sustainablepulse.com/2014/02/19/roundup-linked-global-boom-celiac-disease-gluten-intolerance/

 

http://www.naturalnews.com/024132.html  almond fumigation

Source of “Nut Allergies”

Almond Growers Sue USDA to Halt Mandatory Chemical Fumigation of Raw Almonds

Wednesday, September 10, 2008
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles…)
Tags: almonds, health news, Natural News

Excerpted from above:

After having their organic almond businesses devastated by the USDA’s bizarre decision requiring mandatory chemical fumigation of almonds, the almond industry is fighting back. Fifteen American almond growers have filed a lawsuit against the USDA in an attempt to repeal the requirements that all almonds grown in California be fumigated or pasteurized. (Virtually all almonds sold in the United States are grown in California.)

……..only explanation for the USDA’s insistence that the U.S. food supply should be fumigated, irradiated and cooked to the point of nutrient destruction is that the USDA is pursuing a campaign of intentional nutrient depletion for the U.S. population. With Big Pharma now deciding key regulatory decisions of the U.S. government, the USDA’s actions seemed designed to create a nation of health degenerates who will demand unprecedented levels of pharmaceutical “treatments” that enrich the drug companies.

 

Source of Lactose Intolerance

https://clinicaltrials.gov/ct2/show/NCT03008252

Full reprint below

Lactose Intolerance and Cow’s Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified January 2017 by Pasquale Mansueto, University of Palermo

Sponsor:

University of Palermo

Information provided by (Responsible Party):

Pasquale Mansueto, University of Palermo

ClinicalTrials.gov Identifier:

NCT03008252

First received: December 29, 2016

Last updated: January 9, 2017

Last verified: January 2017

History of Changes

Purpose

In the last few years a new clinical entity has emerged which includes patients who consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested the term “non-celiac wheat sensitivity” (NCWS), because it is not known to date what component of wheat actually causes the symptoms. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal or systemic manifestations (headache, depression, anxiety, ‘foggy mind,’ tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Lactose intolerance and cow’s milk protein allergy (CMPA) are two medical conditions with a very high prevalence in the general population, and there is a large overlap between NCWS symptoms and lactose intolerance and CMPA symptoms. Therefore, the aims of the present study are to investigate 1) the prevalence of positive lactose breath test and DBPC cow’s milk protein challenge in NCWS patients with self-reported gastrointestinal symptoms related to milk and/or milk derivates ingestion, 2) the clinical, serological, and histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison to NCWS patients without lactose intolerance and CMPA.

 

Condition Intervention
Non-celiac Wheat Sensitivity Other: Lactose breath test
Other: DBPC cow’s milk protein challenge

 

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lactose Intolerance and Cow’s Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients

 

Resource links provided by NLM:

 

Genetics Home Reference related topics: lactose intolerance

MedlinePlus related topics: Allergy Lactose Intolerance

U.S. FDA Resources

 

Further study details as provided by Pasquale Mansueto, University of Palermo:

 

Primary Outcome Measures:

  • Positive lactose breath test and DBPC cow’s milk protein challenge in NCWS patients self-reporting symptoms related to milk and/or milk derivates ingestion. [ Time Frame: January 2017 to December 2017 ]

Prevalence of positive lactose breath test and DBPC cow’s milk protein challenge in NCWS patients with self-reported gastrointestinal and extra-intestinal symptoms related to milk and/or milk derivates ingestion.

 

 

Secondary Outcome Measures:

  • Lactose intolerance and CMPA in NCWS patients [ Time Frame: January 2017 to December 2017 ]

Frequency of lactose intolerance and CMPA in NCWS patients

 

 

Estimated Enrollment: 50
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Intervention Details:

Other: Lactose breath test

Lactose breath test in NCWS patients with symptoms related to milk and/or milk derivates ingestion.

Other: DBPC cow’s milk protein challenge

DBPC cow’s milk protein challenge in NCWS patients with symptoms related to milk and/or milk derivates ingestion.

Detailed Description:

In the last few years, a new clinical entity has emerged which includes patients who consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested the term “non-celiac wheat sensitivity” (NCWS), because it is not known to date what component of wheat actually causes the symptoms. Other areas of doubt in NCWS regard its pathogenesis, while some papers reported intestinal immunologic activation, others linked NCWS to the dietary short chain carbohydrate (fermentable oligo-di-monosaccharides and polyols, FODMAPs) load. The researchers recently demonstrated that higher proportions of patients with NCWS develop autoimmune disorders, are antinuclear antibodies (ANA) positive, and show DQ2/DQ8 haplotypes compared with patients with irritable bowel syndrome (IBS), supporting an immunologic involvement in NCWS. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal or systemic manifestations (headache, depression, anxiety, ‘foggy mind,’ tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Lactose intolerance and cow’s milk protein allergy (CMPA) are two conditions with a very high prevalence in the general population and there is a large overlap between NCWS and lactose intolerance and CMPA symptoms. Therefore, the aims of the present study are to investigate 1) the prevalence of positive lactose breath test and DBPC cow’s milk protein challenge in NCWS patients with self-reported gastrointestinal and extra-intestinal symptoms related to milk and/or milk derivates ingestion, 2) the clinical, serological, and histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison to NCWS patients without lactose intolerance and CMPA.

Eligibility

Ages Eligible for Study: 18 Years to 65 Years   (Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

The researchers prospectively will survey adult patients with functional gastroenterological symptoms (Rome III criteria) and a definitive diagnosis of NCWS, referred at the Department of Internal Medicine at the University Hospital of Palermo, Italy, and at the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy, between January 2017 and January 2019, comparing the characteristics of the ones suffering from lactose intolerance and CMPA with those who do not suffer from lactose intolerance and CMPA.

Criteria

Inclusion Criteria:

All the NCWS patients will meet the recently proposed criteria:

  • negative serum anti-tissue transglutaminase and antiendomysium (EmA) IgA and IgG antibodies
  • absence of intestinal villous atrophy
  • IgE-mediated immunoallergy tests negative to wheat and cow’s milk protein (skin prick tests and/or serum specific IgE detection).

Adjunctive criteria adopted in our patients will be:

  • resolution of the gastrointestinal and extra-intestinal symptoms on a standard elimination diet, without wheat, cow’s milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms
  • symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge, performed as described previously.

Exclusion Criteria:

Exclusion criteria will be:

  • age <18 years
  • positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal
  • self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
  • other organic cutaneous and/or gastrointestinal diseases
  • concomitant treatment with steroids and/or antihistamines.

Lactose intolerance and CMPA will be diagnosed, in patients with self-reported gastrointestinal and extra-intestinal symptoms related to milk and/or milk derivates ingestion, using lactose breath test and DBPC cow’s milk protein challenge, respectively.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03008252

Contacts

Contact: Antonio Carroccio, PhD +390916552884 acarroccio@hotmail.com
Contact: Pasquale Mansueto, MD +390916552884 pasquale.mansueto@unipa.it
Locations
Italy
Internal Medicine Department of the Hospital of Sciacca (Agrigento)
Sciacca, Agrigento, Italy, 92019
Internal Medicine Department of the University Hospital of Palermo
Palermo, Italy, 90127

Sponsors and Collaborators

University of Palermo

Investigators

Study Director: Antonio Carroccio, PhD University of Palermo

More Information
Publications:

Carroccio A, Mansueto P, Iacono G, Soresi M, D’Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.

Mansueto P, Seidita A, D’Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996. Review.

Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22.

Carroccio A, D’Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24.

Carroccio A, Soresi M, D’Alcamo A, Sciumè C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.

Mansueto P, Seidita A, D’Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18. Review.

Carroccio A, Brusca I, Mansueto P, D’alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow’s milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.

Carroccio A, Montalto G, Custro N, Notarbartolo A, Cavataio F, D’Amico D, Alabrese D, Iacono G. Evidence of very delayed clinical reactions to cow’s milk in cow’s milk-intolerant patients. Allergy. 2000 Jun;55(6):574-9.

Carroccio A, Montalto G, Cavera G, Notarbatolo A. Lactose intolerance and self-reported milk intolerance: relationship with lactose maldigestion and nutrient intake. Lactase Deficiency Study Group. J Am Coll Nutr. 1998 Dec;17(6):631-6.

 

Responsible Party: Pasquale Mansueto, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT03008252     History of Changes
Other Study ID Numbers: ACPM12
Study First Received: December 29, 2016
Last Updated: January 9, 2017
Individual Participant Data
Plan to Share IPD: No

Keywords provided by Pasquale Mansueto, University of Palermo:

Non-celiac wheat sensitivity
lactose intolerance
cow’s milk protein allergy

Additional relevant MeSH terms:

Hypersensitivity
Lactose Intolerance
Milk Hypersensitivity
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on June 02, 2017

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