Study Stopped
insufficient recruitment
GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity
GLUTN
Sponsor study identifier
interventional
20
1 country
1
Study Start
October 27, 2021
Actual (reported)Primary Completion
March 24, 2023
Actual (reported)Study Completion
March 24, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2021
Actual (reported)March 24, 2023
Actual (reported)March 24, 2023
Actual (reported)March 29, 2024
Actual (reported)April 4, 2024
Actual (reported)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).
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chu Estaing
Clermont-Ferrand, 63100, France
corinne Bouteloup
University Hospital, Clermont-Ferrand
20 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2024
First Posted
April 4, 2024
Study Start
October 27, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 24, 2023
Actual (reported)Study Completion
March 24, 2023
Actual (reported)Last Updated
April 4, 2024
Record last verified: 2024-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: