Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains

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

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2021-11-15

Brief Summary

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The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients using the product

Group Type EXPERIMENTAL

Lactichoc

Intervention Type DIETARY_SUPPLEMENT

dosage form: mix of 8 strains containing 1.2x10\^11 CFU frequency, and duration: 2 capsules/day during 10 days

Stool sampling

Intervention Type OTHER

3 stool samples are taken during the study (D0, D10 and D30)

Interventions

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Lactichoc

dosage form: mix of 8 strains containing 1.2x10\^11 CFU frequency, and duration: 2 capsules/day during 10 days

Intervention Type DIETARY_SUPPLEMENT

Stool sampling

3 stool samples are taken during the study (D0, D10 and D30)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having IBS symptomatology meeting the Rome IV criteria;
* Having a IBS-SSS score ≥150 ;
* In a state of general and mental health compatible with participation in the study ;
* Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
* Willing to take stool samples;
* Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product;
* Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online;
* Affiliated to a social security system.

Exclusion Criteria

* Have a history of hypersensitivity to any of the ingredients of the study product;
* Under antibiotic treatment, or having stopped it for less than 14 days;
* Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
* Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study;
* Having a lifestyle incompatible with the study as determined by the investigator;
* Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months;
* Planning to travel extensively during the study period or unable to be contacted in case of emergency;
* Psychologically or linguistically unable to understand and sign the informed consent;
* Participating in another clinical trial or on an exclusion period from a previous clinical trial;
* Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No