TerminatedNot Applicable

GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity

Stopped: insufficient recruitment

France20 participantsStarted 2021-10-27

Plain-language summary

For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Man or woman, aged over 18, suspected of gluten sensitivity defined by the existence of digestive and extradigestive symptoms when consuming foods containing gluten, disappearing in the absence of gluten consumption. * Patient able to provide informed consent to participate in research. * Patient covered by a Social Security plan. Exclusion Criteria: * \- Weight \< 45 kg * Celiac disease: presence of anti-tissue transglutaminase and/or anti-endomysium autoantibodies and/or villous atrophy found on duodenal biopsies. * Wheat allergy: presence of IgE specific to wheat and/or positivity of prick tests and/or patch tests. * Presence of another food intolerance/sensitivity, in particular to vegetables and fruits rich in FODMAPs, excluding lactose intolerance (extremely common, 30 to 50% of the French population). * Presence only of digestive symptoms, without extradigestive symptoms, when consuming foods containing gluten. * Impossibility of eliminating celiac disease: HLA DQ2 or DQ8 patient, for whom we do not have a dosage of anti-transglutaminase/anti-endomysium antibodies and/or duodenal histology on a normal diet containing gluten. * Current special diet: vegetarian diet except ovo-lactovegetarian or ovo-lacto-pescovegetarian (i.e. pesco-vegetarian diet, vegan/vegan diet, macrobiotic diet, etc.), Paleolithic diet, etc. * Pregnant or breastfeeding women. * Treatment in progress or for less than two months with NSAIDs, corticosteroids, antibiotics, prob…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS.

Timeframe: The patient must complete the questionnaire at the end of each week of the basal period (lasting 2 weeks) and the wash-out period (lasting 2 to 3 weeks) and every day of each test period.

Trial details

NCT IDNCT06347341

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-24

View on ClinicalTrials.gov More The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS trials