Probiotics in the Treatment of Irritable Bowel Syndrome

Phase 2

Completed

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

• Registration Number: NCT01837485
• Lead Sponsor: Islamic Azad University, Najafabad Branch

Brief Summary

Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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
Lactol	Lactol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Abdominal pain	Up to 3 months	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
Diarrhea	Up to 3 months	Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.
Constipation	Up to 3 months	Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of