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

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Lactichoc; Other: Stool sampling

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • General practitioners or gastroenterologists consulting in french private offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients using the product	Dietary supplement: Lactichoc; dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days; Other: Stool sampling; 3 stool samples are taken during the study (D0, D10 and D30)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the severity of functional bowel disorders	The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)	Between V2 (Day10) and Day30 (20 days)
Description of the symptomatology	- 10-day average stool consistency according to the Bristol Stool Scale;	V1(Day0), V2 (Day10) and Day30
Description of the symptomatology	- 10-day average daily stool frequency;	V1(Day0), V2 (Day10) and Day30
Description of the symptomatology	- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);	V1(Day0), V2 (Day10) and Day30
Description of the symptomatology	- 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)	V1(Day0), V2 (Day10) and Day30
Description of quality of life	Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)	V1(Day0), V2 (Day10) and Day30
Description of the anxiety-depressive disorders	Evaluated by the Hospital Anxiety and Depression (HAD) scale	V2 (Day10)
Safety (tolerance to treatment)	Calculated with adverse events that may be observed during study period (descriptif results)	V2 (Day10)
Treatment compliance	By counting treatments returned at the V2 visit	V2 (Day10)
Global clinical evaluation	Evaluated by the investigator (V2) by a questionnaire	V2 (Day10)
Global clinical evaluation	Evaluated by the patient (V2 and D30) by a questionnaire	V2 (Day10) and Day30
Evaluation of the satisfaction concerning the product by a questionnaire	Evaluated by the patient	Day30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the stool microbiota composition	Metagenomic analysis	Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30

Collaborators and Investigators

• Sponsor: PiLeJe
• Investigators: Principal Investigator: Dominique DELSART

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: Pil-LACCB-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No