Functional Digestive Disorders Observatory

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 ;

Disqualifiers

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.)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational study

    Other intervention

    Non interventional study

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Functional digestive explorations

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

Time frame
10 years

Secondary outcomes

1

Radiological findings

Luminal dimensions (cm)

Time frame
10 years
2

Clinical data of patients with functional digestive disorders

ethnicity (categorical measure)

Time frame
10 years
3

Gastric emptying study

Gastric emptying time (minutes)

Time frame
10 years
4

EndoFLIP system

Cross-sectional area (CSA) (mm²) measured using the EndoFLIP® system.

Time frame
10 years

Other outcomes

Sponsors and contacts

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