Study of a Management Strategy of Functional Bowel Disord... | NCT05213910

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

NCT05213910

Sponsor

PiLeJe

Status

Completed

Last Update Posted

Apr 6, 2022Actual

Enrollment

189Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Lactichoc
Stool sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2018Actual

Primary Completion Date

Nov 15, 2021Actual

Completion Date

Nov 15, 2021Actual

First Submitted Date

Dec 13, 2021

First Submission Date that Met QC Criteria

Jan 17, 2022

First Posted Date

Jan 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Label	Type	Description	Intervention Names
Patients using the product	Experimental		Dietary Supplement: Lactichoc Other: Stool sampling

Name	Type	Description	Arm Group Labels	Other Names
Lactichoc	Dietary Supplement	dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days	Patients using the product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)
Description of the symptomatology

Other Outcomes

Measure	Description	Time Frame
Evolution of the stool microbiota composition	Metagenomic analysis	Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases