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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213910
• Other study ID #: Pil-LACCB-017
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

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