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Functional Digestive Disorders Observatory

Observatory of Functionnal Digestive Disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04918329
Acronym
OTFI
Enrollment
2000
Registered
2021-06-08
Start date
2020-10-09
Completion date
2030-10-09
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Observatory, functional digestive disorders

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.

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.

Interventions

OTHERObservational study

Non interventional study

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Functional digestive explorations10 yearsGastrointestinal intraluminal pressures (mmHg), recorded during gastrointestinal manometry.

Secondary

MeasureTime frameDescription
Breath tests10 yearsPercentage of hydrogen (H₂) and methane (CH₄) in exhaled breath during breath testing.
Endoscopic findings10 yearsMucosal abnormalities (caterogical variable)
Drug use10 yearsDrug use (categorical variable)
Gastrointestinal symptoms10 yearsRome questionnaire
Symptoms of anxiety and depression10 yearsHAD questionnaire
Gastric emptying study10 yearsGastric emptying time (minutes)
EndoFLIP system10 yearsCross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.
Radiological findings10 yearsLuminal dimensions (cm)
Clinical data of patients with functional digestive disorders10 yearsethnicity (categorical measure)
Rectal barostat10 yearsRectal distension compliance (Ml/mmHg) measured using a rectal barostat.
painful bladder symptom10 yearsPainful bladder score
Anxiety and depression syndrome10 yearsPatient health questionnaire
Anxiety symptoms10 yearsGeneralized Anxiety Disorder questionnaire
Eating behavior assessment10 yearsSCOFF questionnaire
Global health assessment10 yearsPROMIS 10 Score
General Health Questionnaire10 yearsWRQ score
Health assessment10 yearsEQ-5D-5L
Demographic data10 yearsage (years)
Gastrointestinal treatments10 yearsTreatments (categorical measure)
Sleep assessment10 yearsPittsburgh Sleep Quality Index (PSQI)

Countries

France

Contacts

Primary ContactAnne-Marie AL LEROI, Professor
anne-marie.leroi@chu-rouen.fr33232888990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026