Skip to main content
Clinical Trials/NCT01837485
NCT01837485
Completed
Phase 2

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

Islamic Azad University, Najafabad Branch1 site in 1 country82 target enrollmentAugust 2011

Overview

Phase
Phase 2
Intervention
Lactol
Conditions
Irritable Bowel Syndrome
Sponsor
Islamic Azad University, Najafabad Branch
Enrollment
82
Locations
1
Primary Endpoint
Abdominal pain
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Islamic Azad University, Najafabad Branch
Responsible Party
Principal Investigator
Principal Investigator

Mozhdeh Zahiri

Dr.

Islamic Azad University, Najafabad Branch

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

Lactol

Intervention: Lactol

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Abdominal pain

Time Frame: Up to 3 months

Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.

Diarrhea

Time Frame: Up to 3 months

Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.

Constipation

Time Frame: Up to 3 months

Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.

Study Sites (1)

Loading locations...

Similar Trials