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NCT06347341: GLUTN
GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
NA trial testing Clinical study comparing a gluten-containing diet to a gluten-free diet in The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS in 20 participants. Terminated before completion.
24 March 2023
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 27 October 2021 |
| Primary completion | 24 March 2023 |
| Estimated completion | 24 March 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Clinical study comparing a gluten-containing diet to a gluten-free diet
Conditions studied
- The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS — all drugs for The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
18 and older, any sex, with The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06347341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06347341 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06347341.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing