Probiotics in the Treatment of Irritable Bowel Syndrome

April 22, 2013 updated by: Ali Gholamrezaei, Isfahan University of Medical Sciences

Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome

Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 65
  • diagnosis of IBS based on the Rome III criteria
  • willingness to participate

Exclusion Criteria:

  • receiving other probiotics compound during the study
  • receiving antibiotics during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.
Experimental: Probiotic
Drug: Probiotic
Patients in the probiotic group received the probiotic compound Balance® (Protexin Co., Somerset, UK) or similar placebo, twice daily after meal for 14 consecutive days. Balance® capsules contains seven bacteria species including Lactobacillus strains (L. casei, L. rhamnosus, L. acidophilus, and L. bulgaricus), Bifidobacterium strains (B. breve and B. longum), and Streptococcus thermophiles. Total viable count (TVC) is 1 x 108 CFU/per capsule. Other Ingredients are Fructo-oligosaccharide as prebiotic, magnesium stearate, and hydroxypropyl methyl cellulose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: Up to 6 weeks
Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Up to 6 weeks
Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Somaye Farzamnia, MD, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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