The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGSGLUTNNCT06347341
GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
A study testing Clinical study comparing a gluten-containing diet to a gluten-free diet in people with The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS
- What is being tested?
- Clinical study comparing a gluten-containing diet to a gluten-free diet
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2021to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
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- 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, probiotics, food supplement (glutamine, omega3, antioxidants, etc.) and any other treatment likely to interfere with the study (left to the discretion of the patient). 'investigator).
- Current treatment or for less than 18 months with immunosuppressants, chemotherapy.
- History of digestive surgical intervention (except cholecystectomy and appendectomy).
- Any infectious or inflammatory pathology in progress or less than a month old and any other pathology likely to interfere with the protocol (left to the discretion of the investigator).
- Individual under guardianship, curatorship or legal protection, or deprived of freedoms.
- Participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Twenty patients with possible NCGS on clinical examination and after elimination of CD and AB were included in a study monocentric, randomized, double-blind and crossover design, comparing a gluten-containing diet (RAG) to a gluten-free diet (RSG). The inclusion visit included a specific questioning about digestive and extradigestive symptoms triggered by the consumption of foods with gluten, personal and family history of autoimmune disease, allergy, atopic condition. A dietary consultation made it possible to specify the strict and controlled RSG in FODMAPs (basal diet - RB) to be maintained throughout the 6 weeks of study. After an initial period (PI) of 2 weeks with this RB, patients added for 1 week either foods with gluten (8 g of gluten/d - RAG) or gluten-free foods (RSG) (test periods - PT), the 2 PT being separated by a wash-out period (PWO) of 2 to 3 weeks. Digestive and extradigestive symptoms were assessed by the modified Gastrointestinal Symptom Rating Scale (GSRS) using a 7-point Likert scale (1: absent - 7: very severe), at the end of each week of IP and PWO ( D7 and D14) and every day of each PT. If the symptoms were too severe during PT (i.e. sides of 7), the patient was allowed to stop after a minimum of 72 hours of consumption. For the study of markers of inflammation, immunity, intestinal permeability and metabolomic analyses, blood and urine samples were taken at inclusion and at the end of each PT (or at the end premature). The primary endpoint was the difference in GSRS score at the end of the 2 PTs. Statistical analyzes were carried out using mixed models for a crossover design taking into account subject, diet, period, order and sequence effects and their interactions.
- Being tested
- Clinical study comparing a gluten-containing diet to a gluten-free diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical study comparing a gluten-containing diet to a gluten-free dietDietary supplement
The study includes a basal period of 2 weeks, 2 test periods of a maximum duration of 1 week and a wash-out period of 2 to 3 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS.
The GSRS includes 15 digestive symptoms and 9 extradigestive symptoms, rated on a LIKERT scale from 1 (no symptoms) to 7 (extremely severe symptoms).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start27 Oct 2021
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGSStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, crossover, randomized, double-blind clinical study comparing a gluten-containing diet to a gluten-free diet.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, UCA (UFR de Médecine et UFR Pharmacie)
- Responsible party
- Sponsor
- Investigators
- corinne Bouteloup, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347341
- Sponsor's protocol ID
- 2019-A02014-53
- Acronym
- GLUTN
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
- ClinicalTrials.gov ID
- NCT06347341
- Acronym / sponsor ID
- GLUTN / 2019-A02014-53
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, UCA (UFR de Médecine et UFR Pharmacie)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty patients with possible NCGS on clinical examination and after elimination of CD and AB were included in a study monocentric, randomized, double-blind and crossover design, comparing a gluten-containing diet (RAG) to a gluten-free diet (RSG). The inclusion visit included a specific questioning about digestive and extradigestive symptoms triggered by the consumption of foods with gluten, personal and family history of autoimmune disease, allergy, atopic condition. A dietary consultation made it possible to specify the strict and controlled RSG in FODMAPs (basal diet - RB) to be maintained throughout the 6 weeks of study. After an initial period (PI) of 2 weeks with this RB, patients added for 1 week either foods with gluten (8 g of gluten/d - RAG) or gluten-free foods (RSG) (test periods - PT), the 2 PT being separated by a wash-out period (PWO) of 2 to 3 weeks. Digestive and extradigestive symptoms were assessed by the modified Gastrointestinal Symptom Rating Scale (GSRS) using a 7-point Likert scale (1: absent - 7: very severe), at the end of each week of IP and PWO ( D7 and D14) and every day of each PT. If the symptoms were too severe during PT (i.e. sides of 7), the patient was allowed to stop after a minimum of 72 hours of consumption. For the study of markers of inflammation, immunity, intestinal permeability and metabolomic analyses, blood and urine samples were taken at inclusion and at the end of each PT (or at the end premature). The primary endpoint was the difference in GSRS score at the end of the 2 PTs. Statistical analyzes were carried out using mixed models for a crossover design taking into account subject, diet, period, order and sequence effects and their interactions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Model description
- Prospective, crossover, randomized, double-blind clinical study comparing a gluten-containing diet to a gluten-free diet.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical study comparing a gluten-containing diet to a gluten-free dietThe study includes a basal period of 2 weeks, 2 test periods of a maximum duration of 1 week and a wash-out period of 2 to 3 weeks. | Dietary supplement | – |
Primary outcome
The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS.
Time frame: 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.
The GSRS includes 15 digestive symptoms and 9 extradigestive symptoms, rated on a LIKERT scale from 1 (no symptoms) to 7 (extremely severe symptoms).
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
corinne Bouteloup principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical study comparing a gluten-containing diet to a gluten-free diet in people with The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.