Status:
COMPLETED
Mind-body Approach and Gut Microbiota in Osteoarthritis
Lead Sponsor:
Tufts Medical Center
Conditions:
Osteoarthritis
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
This exploratory study is to compares mechanisms of mind-body exercise with wellness education program on gut microbiota for osteoarthritis as a basis for a future large-scale trial.
Detailed Description
This exploratory study is to determine the effect of mind-body exercise on gut microbiota in patients with osteoarthritis. We will randomize 80 eligible individuals who meet the American College of Rh...
Eligibility Criteria
Inclusion
- Age ≥ 55 years
- Fulfills the American College of Rheumatology Criteria for symptomatic OA
- Baseline (Month 0) WOMAC pain subscale score ≥ 40
Exclusion
- Dementia, neurological disease, cancer, cardiovascular disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the programs.
- Factors known or likely to impact the intestinal microbiota or known to be associated with microbial translocation: antibiotic or probiotic use within the previous 4 weeks, gastrointestinal morbidity (irritable bowel syndrome, inflammatory bowel disease, history of gastrointestinal cancer or surgical resection, or acute, severe gastrointestinal symptoms requiring medical attention), opportunistic infection, and evidence of hepatitis B or C virus infection
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05186714
Start Date
November 1 2022
End Date
June 1 2025
Last Update
September 9 2025
Active Locations (1)
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1
Tufts Medical Center, Rheumatology
Boston, Massachusetts, United States, 02111