Probiotics in the Treatment of Irritable Bowel Syndrome

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Probiotic

• Registration Number: NCT01837472
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-01
• Status Verified: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Probiotic	Probiotic	-

Primary Outcome Measures

Name	Time	Method
Abdominal pain	Up to 6 weeks	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Up to 6 weeks	Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.

Trial Locations

Locations (1)

Department of Gastroenterology, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of