Clinical trial NCT05213910: Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Official title: Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of the severity of functional bowel disorders
timeFrame: 10 days
Secondary outcomes:
measure: Evolution of the severity of functional bowel disorders
timeFrame: Between V2 (Day10) and Day30 (20 days)
measure: Description of the symptomatology
timeFrame: V1(Day0), V2 (Day10) and Day30
measure: Description of the symptomatology
timeFrame: V1(Day0), V2 (Day10) and Day30
measure: Description of the symptomatology
timeFrame: V1(Day0), V2 (Day10) and Day30
measure: Description of the symptomatology
timeFrame: V1(Day0), V2 (Day10) and Day30
measure: Description of quality of life
timeFrame: V1(Day0), V2 (Day10) and Day30
measure: Description of the anxiety-depressive disorders
timeFrame: V2 (Day10)
measure: Safety (tolerance to treatment)
timeFrame: V2 (Day10)
measure: Treatment compliance
timeFrame: V2 (Day10)
measure: Global clinical evaluation
timeFrame: V2 (Day10)
measure: Global clinical evaluation
timeFrame: V2 (Day10) and Day30
measure: Evaluation of the satisfaction concerning the product by a questionnaire
timeFrame: Day30
Other outcomes:
measure: Evolution of the stool microbiota composition
timeFrame: Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30
Locations:
city: Paris
country: France
facility: General practitioners or gastroenterologists consulting in french private offices
Study officials:
name: Dominique DELSART
role: PRINCIPAL_INVESTIGATOR
References: