Functional Digestive Disorders Observatory

Recruiting

• Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Constipation; Faecal Incontinence

• Registration Number: NCT04918329
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.

Detailed Description

Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response. The investigators hope that a better knowledge of the pathophysiology of digestive functional diseases will improve the therapeutic management by making a therapeutic choice based on the observed pathophysiological abnormalities.

Study Timeline

• Study Start: 2020-10-09
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-05
• Study First Posted: 2021-06-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-08
• Last Update Posted: 2023-04-11
• Primary Completion: 2030-10-09
• Study Completion: 2030-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients over 18 years of age;
• Patients with functional digestive disorder for more of 3 months;
• Patients assessed as part of routine care;
• Patients affiliated to the Social Security ;
• Patients not opposed to participation in the Centre

Exclusion Criteria

• Person deprived of liberty by administrative or judicial decision or major protected subject (under guardianship or curatorship);
• Patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Rectal sensitivity and intestinal permeability	10 years	Relation betwenne rectal volume (ml) and intestinal permeability

Secondary Outcome Measures

Name	Time	Method
Correlation betwenne rectal sensitivity and fecal concentration of zonuline	10 years

Trial Locations

Locations (1)

Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont; 🇫🇷 Rouen, France