Status:
COMPLETED
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Lead Sponsor:
PiLeJe
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT05213910
Start Date
September 4 2018
End Date
November 15 2021
Last Update
April 6 2022
Active Locations (1)
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1
General practitioners or gastroenterologists consulting in french private offices
Paris, France