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Completed

NCT Number: NCT05213910

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General practitioners or gastroenterologists consulting in french private offices

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactichoc

Dietary Supplement

dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days

Stool sampling

Other

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

Primary outcomes

  1. Evolution of the severity of functional bowel disorders

    Time frame: 10 days

    The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

Secondary outcomes

  1. Evolution of the severity of functional bowel disorders

    Time frame: Between V2 (Day10) and Day30 (20 days)

    The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

  2. Description of the symptomatology

    Time frame: V1(Day0), V2 (Day10) and Day30

    • 10-day average stool consistency according to the Bristol Stool Scale;
  3. Description of the symptomatology

    Time frame: V1(Day0), V2 (Day10) and Day30

    • 10-day average daily stool frequency;
  4. Description of the symptomatology

    Time frame: V1(Day0), V2 (Day10) and Day30

    • 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
  5. Description of the symptomatology

    Time frame: V1(Day0), V2 (Day10) and Day30

    • 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)
  6. Description of quality of life

    Time frame: V1(Day0), V2 (Day10) and Day30

    Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)

  7. Description of the anxiety-depressive disorders

    Time frame: V2 (Day10)

    Evaluated by the Hospital Anxiety and Depression (HAD) scale

  8. Safety (tolerance to treatment)

    Time frame: V2 (Day10)

    Calculated with adverse events that may be observed during study period (descriptif results)

  9. Treatment compliance

    Time frame: V2 (Day10)

    By counting treatments returned at the V2 visit

  10. Global clinical evaluation

    Time frame: V2 (Day10)

    Evaluated by the investigator (V2) by a questionnaire

  11. Global clinical evaluation

    Time frame: V2 (Day10) and Day30

    Evaluated by the patient (V2 and D30) by a questionnaire

  12. Evaluation of the satisfaction concerning the product by a questionnaire

    Time frame: Day30

    Evaluated by the patient

Other outcomes

  1. Evolution of the stool microbiota composition

    Time frame: Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30

    Metagenomic analysis

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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