MedTrace Logo

Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea

NCT01667627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-05-24

No results posted yet for this study

Summary

We present the study design of a clinical trial designed to assess the clinical effects of the multispecies probiotic combination "BIO-25" in IBS-D patients. To this aim the primary endpoints of the study will be improvement in abdominal pain and stool consistency. The study will also be designed and powered to investigate the effect of the probiotic BIO-25 on the putative inflammation-associated parameters related to microinflammation in IBS, using postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic status.

Conditions

  • IBS

Interventions

DIETARY_SUPPLEMENT

Bio-25

Each capsule of the multispecies probiotic combination Bio-25 consists of 25 billion live bacteria. Each type of bio-25 contains billions of live lactic acid bacteria in defined ratios of lyophilized Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasein, Lactobacillus casei, Bifidobacterium bifidum,Lactobacillus lactis, Lactobacillus rhamnosus,and Streptococcus thermophilus.

OTHER

Placebo

Identical placebo

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ami Sperber, MD · Tel Aviv Medical Center

  • Roy Dekel, MD · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01667627 on ClinicalTrials.gov