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Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome

NCT01276626 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.

Conditions

  • Irritable Bowel Syndrome
  • IBS

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium longum

Powder containing Bifidobacterium longum in maltodextrin.

OTHER

Maltodextrin

Powder containing only maltodextrin

Sponsors & Collaborators

Principal Investigators

  • Peter McLean, PhD · Société des Produits Nestlé (SPN)

  • Premysl Bercik, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT01276626 on ClinicalTrials.gov