Functional Digestive Disorders Observatory

NCT04918329 | Recruiting

• 1 other identifier: 2019/120/OB
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Dyspepsia; Functional Constipation; Faecal Incontinence; Abdominal Pain (AP); Vomiting Syndrome

Keywords

Observatory; functional digestive disorders

Outcome Measures

Primary Outcomes (1)

• Functional digestive explorations

  Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.

  10 years

Secondary Outcomes (45)

• Radiological findings

  10 years

• Clinical data of patients with functional digestive disorders

  10 years

• Gastric emptying study

  10 years

• EndoFLIP system

  10 years

• Rectal barostat

  10 years

Interventions

Observational study OTHER

Non interventional study

Also known as: Non interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with functional digestive disorders consulting in our centre functional digestive disorders whether or not they are sequelae of an organic pathology.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont

Rouen, 76031, France

RECRUITING

Related Publications (2)

• Soliman H, Wuestenberghs F, Desprez C, Leroi AM, Melchior C, Gourcerol G. Physiological characterization of gastric emptying using high-resolution antropyloroduodenal manometry. Am J Physiol Gastrointest Liver Physiol. 2024 Jan 1;326(1):G16-G24. doi: 10.1152/ajpgi.00101.2023. Epub 2023 Oct 24.

  PMID: 37874655 DERIVED

• Gourcerol G, Melchior C, Wuestenberghs F, Desprez C, Prevost G, Grosjean J, Leroi AM, Tavolacci MP. Delayed gastric emptying as an independent predictor of mortality in gastroparesis. Aliment Pharmacol Ther. 2022 Apr;55(7):867-875. doi: 10.1111/apt.16827. Epub 2022 Feb 20.

  PMID: 35187671 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, fecaes, biopsies, urine,

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dyspepsia; Encopresis; Abdominal Pain

Interventions

Observation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Anne-Marie AL LEROI, Professor

CONTACT

33232888990; anne-marie.leroi@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 8, 2021
• Study Start: October 9, 2020
• Primary Completion (Estimated): October 9, 2030
• Study Completion (Estimated): October 9, 2030
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)