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

NCT06347341 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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

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.

Sponsors & Collaborators

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    collaborator OTHER

  • UCA (UFR de Médecine et UFR Pharmacie)

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • corinne Bouteloup · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2023-03-24
Completion
2023-03-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347341 on ClinicalTrials.gov