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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213910
Other study ID # Pil-LACCB-017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2018
Est. completion date November 15, 2021

Study information

Verified date December 2021
Source Larena SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date November 15, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France General practitioners or gastroenterologists consulting in french private offices Paris

Sponsors (1)

Lead Sponsor Collaborator
PiLeJe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Evolution of the stool microbiota composition Metagenomic analysis Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30
Primary 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 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)
Secondary Description of the symptomatology - 10-day average stool consistency according to the Bristol Stool Scale; V1(Day0), V2 (Day10) and Day30
Secondary Description of the symptomatology - 10-day average daily stool frequency; V1(Day0), V2 (Day10) and Day30
Secondary 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
Secondary 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
Secondary Description of quality of life Evaluated by the GIQLI (Gastrointestinal Quality of Life Index) V1(Day0), V2 (Day10) and Day30
Secondary Description of the anxiety-depressive disorders Evaluated by the Hospital Anxiety and Depression (HAD) scale V2 (Day10)
Secondary Safety (tolerance to treatment) Calculated with adverse events that may be observed during study period (descriptif results) V2 (Day10)
Secondary Treatment compliance By counting treatments returned at the V2 visit V2 (Day10)
Secondary Global clinical evaluation Evaluated by the investigator (V2) by a questionnaire V2 (Day10)
Secondary Global clinical evaluation Evaluated by the patient (V2 and D30) by a questionnaire V2 (Day10) and Day30
Secondary Evaluation of the satisfaction concerning the product by a questionnaire Evaluated by the patient Day30
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