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

Irritable Bowel Syndrome Clinical Trial

Official title:

Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662502
• Other study ID #: Floravie
• Status: Completed
• Start date: November 22, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: March 2021
• Source: Biocodex
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 26, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Bifidobacterium longum 35624
Bifidobacterium longum 35624, 1 x 10^9 CFU/capsule, 1 capsule/day over 1 month

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Biocodex

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).	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.	Assessed at baseline and after 1 month of treatment
Secondary	Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).	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.	Assessed at baseline and after 1 month of treatment
Secondary	IBS Symptom Severity	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)	Assessed at baseline and after 1 month of treatment
Secondary	Change of Stool consistency	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.	Assessed at baseline, day10, day 20 and day 30
Secondary	Compliance to the treatment	Compliance assessed with patient self-report on a diary	Assessed after 1 month of treatment
Secondary	Patient satisfaction	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	Assessed after 1 month of treatment
Secondary	Patient's overall impression after 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."	Assessed after 1 month of treatment
Secondary	Physician's satisfaction	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	Assessed after 1 month of treatment