Rheumatoid Arthritis Clinical Trial
Official title:
Effects of Probiotics on Rheumatoid Arthritis Patients
Verified date | September 2017 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 that specifically selected probiotics, Lactobacillus rhamnosus GR-1 and L.
reuteri RC-14, can alleviate symptoms of RA and thereby increase the daily activity of these
patients.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Are between the ages of 18 to 80 2. Are clinically diagnosed with RA (according to ACR criteria) 3. 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). 4. Have at least 4 swollen and tender joints on a 64/66 scale 5. 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). 6. Patients who did not meet any of the exclusion criteria stated below. Exclusion Criteria: 1. Receiving ongoing immunotherapy for RA 2. Has inflammatory bowel disease or leaky gut 3. Currently consuming probiotics and refuse to have a two week washout period 4. Have known allergies to any component in the study product or placebo 5. Plan to have surgery during the time of the study 6. Mental illness impairing ability to comply with study 7. Women who are pregnant or plan to get pregnant during the study period 8. Women who are breastfeeding 9. Consumption of probiotic-containing products during study treatment 10. Patients participating in another NHP clinical trial 11. Patients enrolled in another clinical trial in the past 3 month 12. Women who are breastfeeding |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Health Care | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | St. Joseph's Health Care London, University of Western Ontario, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome will be the number of patients that achieve an ACR20 response. So we will compare the number of patients that achieved an ACR20 response in the probiotic group to those that achieved an ACR20 response in the placebo group. | 4 months | ||
Secondary | Immunological parameters (TNFa, IL-12, IL-10 and G-CSF) along with the eight components of the ACR20 response will be the secondary outcomes. Serum creatinine and liver function will be evaluated as parameters of any side effects of the probiotics. | 4 months |
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