Clinical trial NCT04662502: Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity
Official title: Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult outpatients with IBS consulting a gastroenterologist

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
timeFrame: Assessed at baseline and after 1 month of treatment
Secondary outcomes:
measure: Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
timeFrame: Assessed at baseline and after 1 month of treatment
measure: IBS Symptom Severity
timeFrame: Assessed at baseline and after 1 month of treatment
measure: Change of Stool consistency
timeFrame: Assessed at baseline, day10, day 20 and day 30
measure: Compliance to the treatment
timeFrame: Assessed after 1 month of treatment
measure: Patient satisfaction
timeFrame: Assessed after 1 month of treatment
measure: Patient's overall impression after treatment
timeFrame: Assessed after 1 month of treatment
measure: Physician's satisfaction
timeFrame: Assessed after 1 month of treatment
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
Study officials:
affiliation: Biocodex
name: Gyasi K Johnson, PhD
role: STUDY_DIRECTOR
References: