Status:
COMPLETED
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome
Lead Sponsor:
The Canadian College of Naturopathic Medicine
Collaborating Sponsors:
Wakunaga Pharmaceutical Co., Ltd.
Dicentra Inc.
Conditions:
Irritable Bowel Syndrome
Digestive System Diseases
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
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 disor...
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 id...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01887834
Start Date
June 1 2013
End Date
July 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2