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

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Kyodophilus multi-strain probiotic capsules

The Kyo-Dophilus study product is a gelatin capsule containing three proprietary probiotic bacterial strains. The total quantity of bacteria per capsule is 1.5 billion colony forming units (1.5 x 109 cfu) and is composed of the following strains: * Lactobacillus gasseri KS-13 1.2 * Bifidobacterium bifidum G9-1 0.15 * Bifidobacterium longum MM-2 0.15 Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.

DIETARY_SUPPLEMENT

Kyodophilus Matching Placebo Capsules

Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.

Sponsors & Collaborators

• Wakunaga Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Dicentra Inc.

  collaborator INDUSTRY

• The Canadian College of Naturopathic Medicine

  lead OTHER

Principal Investigators

• Dugald Seely, ND · The Canadian College of Naturopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• Canada

Study Locations