NCT01887834

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The Canadian College of Naturopathic Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Irritable Bowel Syndrome
• Digestive System Diseases
• Colonic Diseases, Functional
• Colitis, Mucous
• Colon, Irritable

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kyodophilus multi-strain probiotic capsules
DIETARY_SUPPLEMENT	Kyodophilus Matching Placebo Capsules

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-06-27
• Last updated: 2015-03-17

Locations

1 site across 1 country: Canada