Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome; Digestive System Diseases; Colonic Diseases, Functional; Colitis, Mucous; Colon, Irritable
MeSH terms: Irritable Bowel Syndrome; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

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 description: 
      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.
    

Intervention name(s): Kyodophilus multi-strain probiotic capsules; Kyodophilus Matching Placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bloating; constipation; diarrhea; gas; mucous; cramping