Clinical trial NCT05186714: Mind-body Approach and Gut Microbiota in Osteoarthritis
Official title: Mind-body Approach and Gut Microbiota in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 73
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Rheumatology criteria for osteoarthritis into Tai Chi or wellness education interventions for 12 weeks. Using 16S rRNA amplicon sequencing of fecal DNA samples we will compare the changes in gut microbiota profiles using 16S rRNA gene amplicon sequencing, and quantity of Streptococcus species using quantitative PCR, as well as their association with clinical outcomes. This exploratory study will guide the development of theoretically informed, effective treatment for a high-risk population further enlighten us about the pathogenesis of metabolic osteoarthritis pain.This proposal will provide crucial preliminary knowledge of the mechanism underlying Tai Chi mind-body therapy for metabolic osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 55 years
* Fulfills the American College of Rheumatology Criteria for symptomatic OA
* Baseline (Month 0) WOMAC pain subscale score ≥ 40

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gut microbiota
timeFrame: From Week 0, to Week 12
Secondary outcomes:
measure: Change in Western Ontario and McMaster University Index (WOMAC)
timeFrame: From Week 0 to Week 12
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: From Week 0 to Week 12
measure: Change in Body mass index
timeFrame: From Week 0 to Week 12
measure: PROMIS-29
timeFrame: From Week 0 to Week 12
measure: Patient Global, 0-100 cm VAS
timeFrame: From Week 0 to Week 12
measure: PROMIS Pain Interference
timeFrame: From Week 0 to Week 12
measure: Arthritis Self-efficacy
timeFrame: From Week 0 to Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center, Rheumatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Chenchen Wang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: