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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Lactichoc; Other: Stool sampling

• Registration Number: NCT05213910
• Lead Sponsor: PiLeJe

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-04
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2021-12
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-28
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients using the product	Lactichoc	-
Patients using the product	Stool sampling	-

Primary Outcome Measures

Name	Time	Method
Evolution of the severity of functional bowel disorders	10 days	The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

Secondary Outcome Measures

Name	Time	Method
Description of the symptomatology	V1(Day0), V2 (Day10) and Day30	- 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)
Global clinical evaluation	V2 (Day10) and Day30	Evaluated by the patient (V2 and D30) by a questionnaire
Evolution of the severity of functional bowel disorders	Between V2 (Day10) and Day30 (20 days)	The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Safety (tolerance to treatment)	V2 (Day10)	Calculated with adverse events that may be observed during study period (descriptif results)
Description of the anxiety-depressive disorders	V2 (Day10)	Evaluated by the Hospital Anxiety and Depression (HAD) scale
Evaluation of the satisfaction concerning the product by a questionnaire	Day30	Evaluated by the patient
Description of quality of life	V1(Day0), V2 (Day10) and Day30	Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Treatment compliance	V2 (Day10)	By counting treatments returned at the V2 visit

Trial Locations

Locations (1)

General practitioners or gastroenterologists consulting in french private offices; 🇫🇷 Paris, France