Status:
COMPLETED
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
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 Irritable Bowel Syndrome. The primary objective of this trial is t...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18-64
- A diagnosis of Irritable Bowel Syndrome as per ROME III criteria
- A classification of mild irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score \>75)
- 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 two 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 consuming probiotic containing products (e.g. yogurts, etc.)
- Subjects who have recently (\< 3 months) initiated dietary measures to control IBS symptoms
- 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 and that require medication
- Subjects with weight loss, anaemia, inflammatory bowel disease, celiac sprue, 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 the 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 :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01176227
Start Date
May 1 2010
End Date
February 1 2011
Last Update
April 1 2011
Active Locations (1)
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1
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2