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A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation

NCT04997057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-26

No results posted yet for this study

Summary

Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

Conditions

  • Irritable Bowel Syndrome With Constipation

Interventions

DIETARY_SUPPLEMENT

Probiotics mixture

12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing: * Bifidobacterium longum LA 101 * Lactobacillus helveticus La 102 * Lactococcus lactis LA 103 * Streptococcus thermophilus LA 104

Sponsors & Collaborators

  • PiLeJe

    collaborator INDUSTRY

  • CEN Biotech

    lead INDUSTRY

Principal Investigators

  • GABRIEL PERLEMUTER, PR · Hospital Antoine-Béclère

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2022-12-09
Completion
2022-12-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997057 on ClinicalTrials.gov