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Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients

NCT04898257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-24

No results posted yet for this study

Summary

This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.

30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Multistrain probiotic

After completion of screening phase, during baseline visit, eligible patients will be assigned to Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day on an empty stomach (30 minutes before breakfast and 30 minutes before dinner).

Sponsors & Collaborators

  • Larena SAS

    lead INDUSTRY

Principal Investigators

  • Samira Aït Abdellah · Laboratoire PILEJE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-10-08
Completion
2020-11-25

Countries

  • Italy

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 NCT04898257 on ClinicalTrials.gov