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

April 3, 2024 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63100
        • CHU Estaing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
UCA (UFR de Médecine et UFR Pharmacie)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: corinne Bouteloup, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-A02014-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS

Clinical Trials on Clinical study comparing a gluten-containing diet to a gluten-free diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings