Clinical trial NCT04918329: Functional Digestive Disorders Observatory
Official title: Observatory of Functionnal Digestive Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Dyspepsia
Functional Constipation
Faecal Incontinence
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with functional digestive disorders consulting in our centre

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 objective of this study is to collect prospective clinical and tests data and a biological collection from biological 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 objective of this study is to collect prospective clinical and tests data and a biological collection from biological 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.

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.)

Primary outcomes:
measure: Correlation between Rectal sensitivity and intestinal permeability
timeFrame: 10 years
Secondary outcomes:
measure: Correlation betwenne rectal sensitivity and fecal concentration of zonuline
timeFrame: 10 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Study officials:
References:
citation: 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.