Probiotics in the Treatment of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837485
• Other study ID #: 15010101882058
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2013
• Last updated: April 18, 2013
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Islamic Azad University, Najafabad Branch
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Lactol
The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.
• Placebo
Placebo pill was applied 3 times a day for 3 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Najafabad Branch

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.	Up to 3 months	No
Primary	Constipation	Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.	Up to 3 months	No
Primary	Diarrhea	Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.	Up to 3 months	No