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

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

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

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Lactichoc
* Other: Stool sampling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 |