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

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

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

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 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 Irritable Bowel Syndrome.

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 mild through the Irritable Bowel Severity Scoring System and to measuring quality of life and global well being of patients through the Visual Analog Scale and the Irritable Bowel Syndrome-Quality of Life Questioner. The secondary objective is to assess the tolerability of the treatment through the use of study diaries.


Sponsor: The Canadian College of Naturopathic Medicine

Current Primary Outcome: The irrtable bowel severity scoring system is the primary outcome measure [ Time Frame: 12 weeks (between baseline and end of study) ]

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 will be assessed through the use of study diaries in which adverse events will be recorded. [ Time Frame: 12 weeks ]
  • The Irritable Bowel Syndrome-Quality of Life Questionnaire [ Time Frame: 12 weeks (baseline and end of study) ]
    This is a validated quality of life questionnaire (Patrick et al, 1998)
  • Visual Analogue Scale [ Time Frame: 12 weeks (baseline and end of study) ]
    Patient rated 0-6 (7 point)questionnaire on the severity of IBS symptoms


Original Secondary Outcome: Same as current

Information By: The Canadian College of Naturopathic Medicine

Dates:
Date Received: May 31, 2010
Date Started: May 2010
Date Completion:
Last Updated: March 31, 2011
Last Verified: March 2011