Functional Digestive Disorders Observatory

Irritable Bowel Syndrome Clinical Trial

— OTFI  

Official title:

Observatory of Functionnal Digestive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918329
• Other study ID #: 2019/120/OB
• Secondary ID: 2019/120/OB
• Status: Recruiting
• Start date: October 9, 2020
• Est. completion date: October 9, 2030

Study information

• Verified date: April 2023
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 9, 2030
• Est. primary completion date: October 9, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Constipation
• Digestive System Diseases
• Dyspepsia
• Faecal Incontinence
• Fecal Incontinence
• Functional Constipation
• Irritable Bowel Syndrome

Intervention

Other:
• Observational study
Non interventional study

Locations

Country	Name	City	State
France	Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Rectal sensitivity and intestinal permeability	Relation betwenne rectal volume (ml) and intestinal permeability	10 years
Secondary	Correlation betwenne rectal sensitivity and fecal concentration of zonuline		10 years