Clinical Trial: Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Severe Irritable Bowel Syndrome

Brief Summary:

The Canadian College of Naturopathic Medicine is conducting a research study on Irritable Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and bloating.

The medicines that are currently used to help people with IBS are not as effective as we would like them to be. These medicines are usually only prescribed to reduce the pain of IBS and not actually treat the disorder itself. Recently, scientists have found that probiotics (beneficial bacteria that live inside humans) may help reduce the painful symptoms and diarrhea that are part of IBS.

This research is being conducted to determine whether this particular combination of three probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum) will reduce the symptoms of severe IBS.


Detailed Summary:

The purpose of this trial is to investigate the effects of the three strain probiotic, Kyo-Dophilus, on the symptoms associated with severe Irritable Bowel Syndrome. A previous pilot clinical trial identified individuals with severe IBS to be most likely to benefit from the treatment provided in this trial.

The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with Irritable Bowel Syndrome by ROME III criteria and classified as severe through the Irritable Bowel Severity Scoring System and to measure quality of life and global well-being of patients through the Adequate Relief Criteria and the Irritable Bowel Syndrome-Quality of Life Questionnaire.

The secondary objective is to assess the tolerability of the treatment through the use of Adverse Event Reporting Forms.


Sponsor: The Canadian College of Naturopathic Medicine

Current Primary Outcome: Irritable Bowel Syndrome Severity [ Time Frame: 12 weeks ]

Irritable bowel severity scoring system is a validated questionnaire used to monitor IBS (Francis et al, 1997).


Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerability of the treatment [ Time Frame: 12 weeks ]

A standardized Adverse Events Reporting Form will be used to query subjects on the incidence of any side effects, which will be recorded.


Original Secondary Outcome: Same as current

Information By: The Canadian College of Naturopathic Medicine

Dates:
Date Received: June 25, 2013
Date Started: June 2013
Date Completion:
Last Updated: March 10, 2015
Last Verified: March 2015