NCT05213910

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

April 6, 2022

Status Verified

December 1, 2021

Enrollment Period

3.2 years

First QC Date

December 13, 2021

Last Update Submit

April 5, 2022

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 (12)

  • Evolution of the severity of functional bowel disorders

    Between V2 (Day10) and Day30 (20 days)

  • Description of the symptomatology

    V1(Day0), V2 (Day10) and Day30

  • Description of the symptomatology

    V1(Day0), V2 (Day10) and Day30

  • Description of the symptomatology

    V1(Day0), V2 (Day10) and Day30

  • Description of the symptomatology

    V1(Day0), V2 (Day10) and Day30

  • +7 more secondary outcomes

Other Outcomes (1)

  • Evolution of the stool microbiota composition

    Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30

Study Arms (1)

Patients using the product

EXPERIMENTAL
Dietary Supplement: LactichocOther: Stool sampling

Interventions

LactichocDIETARY_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
Stool samplingOTHER

3 stool samples are taken during the study (D0, D10 and D30)

Patients using the product

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General practitioners or gastroenterologists consulting in french private offices

Paris, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dominique DELSART

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 28, 2022

Study Start

September 4, 2018

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

April 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)