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Clinical Trials/NCT01837472
NCT01837472
Completed
Phase 2

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

Isfahan University of Medical Sciences1 site in 1 country132 target enrollmentApril 2012

Overview

Phase
Phase 2
Intervention
Probiotic
Conditions
Irritable Bowel Syndrome
Sponsor
Isfahan University of Medical Sciences
Enrollment
132
Locations
1
Primary Endpoint
Abdominal pain
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
April 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ali Gholamrezaei

Dr.

Isfahan University of Medical Sciences

Eligibility Criteria

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

Arms & Interventions

Probiotic

Intervention: Probiotic

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Abdominal pain

Time Frame: Up to 6 weeks

Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

Secondary Outcomes

  • Quality of Life(Up to 6 weeks)

Study Sites (1)

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