Irritable Bowel Syndrome
Conditions
Brief summary
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
Interventions
DIETARY_SUPPLEMENTLactichoc
dosage form: mix of 8 strains containing 1.2x10\^11 CFU frequency, and duration: 2 capsules/day during 10 days
OTHERStool sampling
3 stool samples are taken during the study (D0, D10 and D30)
Sponsors
PiLeJe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Description of the symptomatology | V1(Day0), V2 (Day10) and Day30 | \- 10-day average stool consistency according to the Bristol Stool Scale; |
| Description of quality of life | V1(Day0), V2 (Day10) and Day30 | Evaluated by the GIQLI (Gastrointestinal Quality of Life Index) |
| Description of the anxiety-depressive disorders | V2 (Day10) | Evaluated by the Hospital Anxiety and Depression (HAD) scale |
| Treatment compliance | V2 (Day10) | By counting treatments returned at the V2 visit |
| Global clinical evaluation | V2 (Day10) | Evaluated by the investigator (V2) by a questionnaire |
| Evaluation of the satisfaction concerning the product by a questionnaire | Day30 | Evaluated by the patient |
| Safety (tolerance to treatment) | V2 (Day10) | Calculated with adverse events that may be observed during study period (descriptif results) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the stool microbiota composition | Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30 | Metagenomic analysis |
Countries
France
Outcome results
None listed