Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04918329
Other study ID # 2019/120/OB
Secondary ID 2019/120/OB
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.)

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3