Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Study Details
Study Description
Brief Summary
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 the symptomatology [V1(Day0), V2 (Day10) and Day30]
- 10-day average daily stool frequency;
- Description of the symptomatology [V1(Day0), V2 (Day10) and Day30]
- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
- 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)
- 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
- Safety (tolerance to treatment) [V2 (Day10)]
Calculated with adverse events that may be observed during study period (descriptif results)
- 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
- Global clinical evaluation [V2 (Day10) and Day30]
Evaluated by the patient (V2 and D30) by a questionnaire
- Evaluation of the satisfaction concerning the product by a questionnaire [Day30]
Evaluated by the patient
Other Outcome Measures
- Evolution of the stool microbiota composition [Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30]
Metagenomic analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Having IBS symptomatology meeting the Rome IV criteria;
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Having a IBS-SSS score ≥150 ;
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In a state of general and mental health compatible with participation in the study ;
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Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
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Willing to take stool samples;
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Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product;
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Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online;
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Affiliated to a social security system.
Exclusion Criteria:
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Have a history of hypersensitivity to any of the ingredients of the study product;
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Under antibiotic treatment, or having stopped it for less than 14 days;
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Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
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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;
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Having a lifestyle incompatible with the study as determined by the investigator;
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Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months;
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Planning to travel extensively during the study period or unable to be contacted in case of emergency;
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Psychologically or linguistically unable to understand and sign the informed consent;
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Participating in another clinical trial or on an exclusion period from a previous clinical trial;
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Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General practitioners or gastroenterologists consulting in french private offices | Paris | France |
Sponsors and Collaborators
- PiLeJe
Investigators
- Principal Investigator: Dominique DELSART,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pil-LACCB-017