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Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study

NCT02371499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-02-02

No results posted yet for this study

Summary

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Lactobacillus casei DG

the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks

DIETARY_SUPPLEMENT

Placebo

the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giorvanni Barbara, MD · Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT02371499 on ClinicalTrials.gov