NCT01837472

Probiotics in the Treatment of Irritable Bowel Syndrome

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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.
DRUG	Placebo	Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2013-04-23
• Last updated: 2013-04-23

Locations

1 site across 1 country: Iran