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

NCT ID: NCT04662502

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-22

Study Completion Date

2020-06-26

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bifidobacterium longum 35624

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocodex

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gyasi K Johnson, PhD

Role: STUDY_DIRECTOR

Biocodex

Locations

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Hôpital Avicenne

Bobigny, , France

Site Status

Countries

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France

Other Identifiers

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Floravie

Identifier Type: -

Identifier Source: org_study_id

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