Functional Digestive Disorders Observatory (OTFI)

Observatory of Functionnal Digestive Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Irritable Bowel Syndrome; Functional Constipation; Vomiting Syndrome; Faecal Incontinence; Abdominal Pain (AP)
• Intervention / Treatment: Other: Observational study

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 pathophysiology of these functional disorders is complex and often multifactorial: digestive motility disorders, digestive sensitivity disorders, sphincter dysfunction, post-surgery, intestinal inflammation, dysbiosis, disruption of the gut-brain axis. For example, it has been shown that one in four patients with proven remission of chronic inflammatory bowel disease reports digestive symptoms compatible with a functional intestinal disorder, suggesting a pathophysiological continuum between these two conditions.

In our center, patients with functional digestive disorders undergo a comprehensive assessment that evolves in line with scientific advances and the emergence of new diagnostic or prognostic tools. This assessment helps to identify the pathophysiological mechanisms involved in the functional digestive disorder: disturbances in digestive motility, visceral hypersensitivity, mucosal alterations, sub-inflammatory syndrome, and dysfunction of the gut-brain axis. All of these abnormalities may be promoted by a genetic predisposition leading to alterations in neurotransmitters, immune function, mucosal integrity, and so on.

Our objective is to study the pathophysiological mechanisms, including genetic factors, responsible for functional digestive disorders as a whole, whether or not they are sequelae of an organic pathology.

To do that, we collect prospective clinical and tests data and we perform 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. 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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Anne-Marie AL LEROI, Professor; Phone Number: 65461 33232888990; Email: anne-marie.leroi@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • Recruiting
    • Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
    • Contact: Anne-Marie Leroi, phd; Phone Number: 00-33-2-32-88-80-39; Email: anne-marie.leroi@chu-rouen.fr
    • Principal Investigator: Anne-marie Leroi, PHd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional digestive explorations	Gastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological findings	Luminal dimensions (cm)	10 years
Clinical data of patients with functional digestive disorders	ethnicity (categorical measure)	10 years
Gastric emptying study	Gastric emptying time (minutes)	10 years
EndoFLIP system	Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.	10 years
Rectal barostat	Rectal distension compliance (Ml/mmHg) measured using a rectal barostat.	10 years
Breath tests	Percentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing.	10 years
Endoscopic findings	Mucosal abnormalities (caterogical variable)	10 years
Drug use	Drug use (categorical variable)	10 years
Gastrointestinal symptoms	Rome questionnaire	10 years
Gastrointestinal symptoms	Bristol Scale	10 years
Gastrointestinal symptoms	Francis score	10 years
Gastrointestinal symptoms	GIQLI score	10 years
Gastrointestinal symptoms	Cleveland Clinic Score	10 years
Gastrointestinal symptoms	FIQL score	10 years
Symptoms of anxiety and depression	HAD questionnaire	10 years
Sleep assessment	Pittsburgh Sleep Quality Index (PSQI)	10 years
Sleep assessment	Insomnia severity index	10 years
painful bladder symptom	Painful bladder score	10 years
Gastrointestinal symptoms	PAGI-SYM score	10 years
Gastrointestinal symptoms	PAGI-QOL	10 years
Gastrointestinal symptoms	Reflux questionnaire RDQ	10 years
Anxiety and depression syndrome	Patient health questionnaire	10 years
Anxiety symptoms	Generalized Anxiety Disorder questionnaire	10 years
Gastrointestinal symptoms	Kess score	10 years
Anxiety symptoms	Generalized Anxiety Disorder	10 years
Gastrointestinal symptoms	Visceral Sensitivity Index (VSI)	10 years
Eating behavior assessment	SCOFF questionnaire	10 years
Eating behavior assessment	ARFID questionnaire	10 years
Sleep assessment	Ford Insomnia Response to Stress Test (FIRST)	10 years
Global health assessment	PROMIS 10 Score	10 years
Gastrointestinal symptoms	IBSQOL score	10 years
General Health Questionnaire	WRQ score	10 years
Gastrointestinal symptoms	Gastroparesis questionnaire	10 years
Gastrointestinal symptoms	Vaizey questionnaire	10 years
Gastrointestinal symptoms	CISS score	10 years
Health assessment	EQ-5D-5L	10 years
Eating behavior assessment	Fear of food score	10 years
Eating behavior assessment	Food avoidance score	10 years
Eating behavior assessment	FITAS score	10 years
Gastrointestinal symptoms	PAC-QOL	10 years
Gastrointestinal symptoms	NBD score	10 years
Gastrointestinal symptoms	LARS score	10 years
Demographic data	age (years)	10 years
Demographic data	sex (categorical measure)	10 years
Gastrointestinal treatments	Treatments (categorical measure)	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Estimated): October 9, 2030
• Study Completion (Estimated): October 9, 2030

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Observatory; functional digestive disorders
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Signs and Symptoms, Digestive; Intestinal Diseases; Behavioral Symptoms; Elimination Disorders; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Irritable Bowel Syndrome; Abdominal Pain; Dyspepsia; Encopresis; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 2019/120/OB (Registry Identifier: Functional Digestive Disorders Observatory)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No