NCT04918329 Functional Digestive Disorders Observatory
| NCT ID | NCT04918329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Irritable Bowel Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-10-09 |
| Primary Completion | 2030-10-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2020-10-09 with a primary completion date of 2030-10-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 pathophysiology of these functional disorders is complex and often multifactorial: disturbances in digestive motility, altered visceral sensitivity, sphincter dysfunction, post-surgery, intestinal inflammation, dysbiosis, and impairment of the gut-brain axis. For example, it has been shown that one in four patients with inflammatory bowel disease in confirmed remission report digestive symptoms consistent with a functional bowel disorder, suggesting a possible pathophysiological continuum between these two conditions. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples (digestive biopsies, blood, urine and fecal samples) collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.
Eligibility Criteria
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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04918329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04918329 currently recruiting?
Yes, NCT04918329 is actively recruiting participants. Contact the research team at anne-marie.leroi@chu-rouen.fr for enrollment information.
Where is the NCT04918329 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT04918329 clinical trial?
NCT04918329 is sponsored by University Hospital, Rouen. The trial plans to enroll 2,000 participants.