Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT04662502
• Lead Sponsor: Biocodex

Brief Summary

The main objective of this observatory is to evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity

Detailed Description

This observatory evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity, after a one-month treatment with Bibidobacterium longum 35624, 1x10\^9 CFU/capsule, 1 capsule/day.

Study Timeline

• Study Start: 2018-11-22
• Primary Completion: 2020-01-29
• Study Completion: 2020-06-26
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Male or female, at least 18 years of age
• Gastroenterology consultation for an Irritable Bowel Syndrome according to Rome IV criteria
• Having received a first prescription of Bifidobacterium longum 35624 during the consultation (independently of participation in the observatory)
• Informed and having declared his/her non-opposition to the study.

Exclusion Criteria

• Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
• Having already taken Bifidobacterium longum 35624
• Having received probiotics or antibiotics within 2 weeks previous
• Having started within the last 7 days a treatment that can interfere with the investigator's evaluation of the investigational product under investigation
• Participant in another trial
• Pregnant or breastfeeding women
• Being under guardianship or curator.
• Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).	Assessed at baseline and after 1 month of treatment	Change from baseline of quality of life as assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL, scoring from 0 to 100, with higher scores indicating better IBS specific quality of life) in IBS patients having different subtypes of transit pattern and different level of symptom severity.

Secondary Outcome Measures

Name	Time	Method
Change of Stool consistency	Assessed at baseline, day10, day 20 and day 30	Change of stool consistency assessed with the Bristol stool scale. The Bristol Stool Chart classifies stool according to their shape and consistency and assigns a sample a number from 1-7 depending on its characteristics, corresponding to constipation normal or diarrhea.
IBS Symptom Severity	Assessed at baseline and after 1 month of treatment	Change of IBS Symptom Severity assessed with the IBS Severity Scoring System (IBS-SSS, scoring from 0 to 500, with higher scores indicating worse severity of IBS symptoms)
Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).	Assessed at baseline and after 1 month of treatment	Change from baseline of quality of life subscores as assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL, scoring from 0 to 100, with higher scores indicating better IBS specific quality of life) in IBS patients having different subtypes of transit pattern and different level of symptom severity.
Patient satisfaction	Assessed after 1 month of treatment	Patient satisfaction with treatment assessed on a 5-point Likert scale, with proposals ranked in ascending order of satisfaction as 1- Not at all satisfied; 2- Unsatisfied; 3- Somewhat satisfied; 4-Satisfied to 5-Very satisfied
Compliance to the treatment	Assessed after 1 month of treatment	Compliance assessed with patient self-report on a diary
Patient's overall impression after treatment	Assessed after 1 month of treatment	The patient's overall impression of how the product has changed his or her daily activities, symptoms, and quality of life, assessed with the Patients' Global Impression of Change (PGIC) scale. PGIC is a 7-point scale describing patient's rating of overall improvement. Change is rated by patients as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Physician's satisfaction	Assessed after 1 month of treatment	Physician satisfaction with the treatment for his/her patient assessed on a 5-point Likert scale, with proposals ranked in ascending order of satisfaction as 1- Not at all satisfied; 2- Unsatisfied; 3- Somewhat satisfied; 4-Satisfied to 5-Very satisfied

Trial Locations

Locations (1)

Hôpital Avicenne; 🇫🇷 Bobigny, France