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

NCT04662502 | Completed

• 1 other identifier: Floravie
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• IBS Symptom Severity

  Assessed at baseline and after 1 month of treatment

• Change of Stool consistency

  Assessed at baseline, day10, day 20 and day 30

• Compliance to the treatment

  Assessed after 1 month of treatment

• Patient satisfaction

  Assessed after 1 month of treatment

Interventions

Bifidobacterium longum 35624 DIETARY_SUPPLEMENT

Bifidobacterium longum 35624, 1 x 10\^9 CFU/capsule, 1 capsule/day over 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult outpatients with IBS consulting a gastroenterologist

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93009, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gyasi K Johnson, PhD

  Biocodex

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 10, 2020
• Study Start: November 22, 2018
• Primary Completion: January 29, 2020
• Study Completion: June 26, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

FR (1)