Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
Irritable Bowel Syndrome, Digestive System Diseases, Colonic Diseases, Functional
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring bloating, constipation, diarrhea, gas, mucous, cramping
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged 18-64.
- A diagnosis of Irritable Bowel Syndrome as per ROME III criteria.
- A classification of severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score >300).
- Female subjects currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods).
- Subjects who agree to maintain their current eating habits throughout the study.
- Ability to understand and sign the Informed Consent Form.
Exclusion Criteria:
- Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months
- Subjects currently receiving medication for the treatment of IBS symptoms.
- Subjects currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the trial is they agree to undergo a four week washout period.
- Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain.
- Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).
- Subjects currently receiving antibiotic therapy or antibiotic therapy within the previous month.
- Subjects regularly (>3 times weekly) consuming probiotics enriched products (e.g. probiotic enriched yogurts, Activia, etc…).
- Subjects who have recently (< 3 months) initiated dietary measures to control IBS symptoms, such as elimination of certain foods.
- Subjects with a history of major or complicated gastrointestinal surgery.
- Subjects with severe endometriosis.
- Subjects with malignant tumors or subjects undergoing chemotherapy or radiation therapy.
- Subjects with severe IBS that require medication for treatment of IBS symptoms.
- Subjects with weight loss, anemia, inflammatory bowel disease, or celiac sprue, and family history of colorectal cancer.
- Subjects exhibiting or indicating thoughts of suicide currently or in the past as based on patient screening interview by the investigator/clinician. Appropriate referral to a health care provider will be provided.
- Subjects with known allergies to milk or milk based products.
- Subjects using and/or have used antipsychotic or anticholinergic medication within the prior month, those with reported significant abnormalities on thyroid function tests, blood counts and serum chemistry.
- Subjects 50 years or older who have been diagnosed with IBS and have not received a colonoscopy in the last five years.
Sites / Locations
- The Canadian College of Naturopathic Medicine
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Kyodophilus matching placebo capsules
Kyodophilus multi strain probiotic capsules
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.
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.