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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lactichoc
Stool sampling
Sponsored by
PiLeJe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General practitioners or gastroenterologists consulting in french private offices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients using the product

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Description of the symptomatology
- 10-day average stool consistency according to the Bristol Stool Scale;
Description of the symptomatology
- 10-day average daily stool frequency;
Description of the symptomatology
- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
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)
Description of quality of life
Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Description of the anxiety-depressive disorders
Evaluated by the Hospital Anxiety and Depression (HAD) scale
Safety (tolerance to treatment)
Calculated with adverse events that may be observed during study period (descriptif results)
Treatment compliance
By counting treatments returned at the V2 visit
Global clinical evaluation
Evaluated by the investigator (V2) by a questionnaire
Global clinical evaluation
Evaluated by the patient (V2 and D30) by a questionnaire
Evaluation of the satisfaction concerning the product by a questionnaire
Evaluated by the patient

Full Information

First Posted
December 13, 2021
Last Updated
April 5, 2022
Sponsor
PiLeJe
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1. Study Identification

Unique Protocol Identification Number
NCT05213910
Brief Title
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Official Title
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PiLeJe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients using the product
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactichoc
Intervention Description
dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days
Intervention Type
Other
Intervention Name(s)
Stool sampling
Intervention Description
3 stool samples are taken during the study (D0, D10 and D30)
Primary Outcome Measure Information:
Title
Evolution of the severity of functional bowel disorders
Description
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Evolution of the severity of functional bowel disorders
Description
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time Frame
Between V2 (Day10) and Day30 (20 days)
Title
Description of the symptomatology
Description
- 10-day average stool consistency according to the Bristol Stool Scale;
Time Frame
V1(Day0), V2 (Day10) and Day30
Title
Description of the symptomatology
Description
- 10-day average daily stool frequency;
Time Frame
V1(Day0), V2 (Day10) and Day30
Title
Description of the symptomatology
Description
- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
Time Frame
V1(Day0), V2 (Day10) and Day30
Title
Description of the symptomatology
Description
- 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)
Time Frame
V1(Day0), V2 (Day10) and Day30
Title
Description of quality of life
Description
Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Time Frame
V1(Day0), V2 (Day10) and Day30
Title
Description of the anxiety-depressive disorders
Description
Evaluated by the Hospital Anxiety and Depression (HAD) scale
Time Frame
V2 (Day10)
Title
Safety (tolerance to treatment)
Description
Calculated with adverse events that may be observed during study period (descriptif results)
Time Frame
V2 (Day10)
Title
Treatment compliance
Description
By counting treatments returned at the V2 visit
Time Frame
V2 (Day10)
Title
Global clinical evaluation
Description
Evaluated by the investigator (V2) by a questionnaire
Time Frame
V2 (Day10)
Title
Global clinical evaluation
Description
Evaluated by the patient (V2 and D30) by a questionnaire
Time Frame
V2 (Day10) and Day30
Title
Evaluation of the satisfaction concerning the product by a questionnaire
Description
Evaluated by the patient
Time Frame
Day30
Other Pre-specified Outcome Measures:
Title
Evolution of the stool microbiota composition
Description
Metagenomic analysis
Time Frame
Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique DELSART
Official's Role
Principal Investigator
Facility Information:
Facility Name
General practitioners or gastroenterologists consulting in french private offices
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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