Status:
COMPLETED
Effects of Probiotics on Rheumatoid Arthritis Patients
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
University of Western Ontario, Canada
St. Joseph's Health Care London
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the present study is to examine the utility of probiotics as an adjunctive therapy (in addition to patients' pharmacotherapy) for the treatment of Rheumatoid Arthritis. We hypothesize ...
Detailed Description
Patients between 18 - 80 years old who have Rheumatoid arthritis with at least 4 swollen and tender joints will be randomized to receive by mouth two capsules containing placebo or probiotic, Lactobac...
Eligibility Criteria
Inclusion
- Are between the ages of 18 to 80
- Are clinically diagnosed with RA (according to ACR criteria)
- Have been on stable RA treatment and are expected to stay on stable RA treatment during the time of the study (i.e. ongoing medication and/or other therapy, such as physiotherapy are permitted, except immunotherapy).
- Have at least 4 swollen and tender joints on a 64/66 scale
- Women of childbearing capacity and who agree to an acceptable method of birth control. Acceptable methods of birth control will include: hormone therapy (oral birth control pills, injectable or skin patches), barrier contraceptive with spermacide, an intra uterine device (IUD) or complete abstinence (no sexual intercourse).
- Patients who did not meet any of the exclusion criteria stated below.
Exclusion
- Receiving ongoing immunotherapy for RA
- Has inflammatory bowel disease or leaky gut
- Currently consuming probiotics and refuse to have a two week washout period
- Have known allergies to any component in the study product or placebo
- Plan to have surgery during the time of the study
- Mental illness impairing ability to comply with study
- Women who are pregnant or plan to get pregnant during the study period
- Women who are breastfeeding
- Consumption of probiotic-containing products during study treatment
- Patients participating in another NHP clinical trial
- Patients enrolled in another clinical trial in the past 3 month
- Women who are breastfeeding
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00664820
Start Date
March 1 2008
End Date
July 1 2009
Last Update
September 15 2017
Active Locations (1)
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1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2