Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

Study Purpose

The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Non-coeliac gluten sensitivity patients.

- Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet.

- Symptoms currently well controlled on a gluten-free diet.

- Adherence to the gluten-free diet for at least 6 weeks prior to recruitment.

- Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype) - IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive.

- Body Mass Index (BMI) of 20 - 25 kg/m2.

- Stable body weight for at least 3 months prior to the start of the study.

Exclusion Criteria:

- Medical.

- Coeliac disease.

- Abdominal or thoracic surgery.

Exception: appendectomy.

- Gastrointestinal, endocrine or neurological diseases.

- Cardiovascular, respiratory, renal or urinary diseases.

- Hypertension.

- Food or drug allergies.

- Psychiatric disorders.

- Eating disorders.

- Depressive disorders.

- Anxiety disorders.

- Psychotic disorders.

- Restraint or emotional eating.

- Medication on a regular basis, exception: oral contraception.

- History of cannabis use or any other drug of abuse for at least 12 months prior to the study.

- Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week) - Pregnant or breastfeeding women

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03798249
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitaire Ziekenhuizen Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	NCGS, Gluten

Arms & Interventions

Arms

Active Comparator: Gluten

Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days

Placebo Comparator: Placebo

Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days

Interventions

Other: - Gluten

Tereos

Other: - Placebo

Nestlé Health Science

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

TARGID, Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

TARGID

Leuven, Vlaams-Brabant,

Site Contact

Annelies Geeraerts

Annelies.Geeraerts@kuleuven.be

016377034

Jan Tack, Leuven, Belgium

Status

Recruiting

Address

Jan Tack

Leuven, , 3000

Site Contact

Jan Tack

jan.tack@med.kuleuven.be

498797124

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