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

March 11, 2021 updated by: Biocodex

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93009
        • Hopital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult outpatients with IBS consulting a gastroenterologist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
Time Frame: 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.
Assessed at baseline and after 1 month of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocodex

Investigators

  • Study Director: Gyasi K Johnson, PhD, Biocodex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2018

Primary Completion (Actual)

January 29, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Floravie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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