Mind-body Approach and Gut Microbiota in Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Mind-body Approach and Gut Microbiota in Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186714
• Other study ID #: 122321
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: Tufts Medical Center
• Contact: Chenchen Wang, MD. MSc
• Phone: 617-636-3251
• Email: cwang2[@]tuftsmedicalcenter.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• Tai Chi versus wellness education
12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)

Locations

Country	Name	City	State
United States	Tufts Medical Center, Rheumatology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	Changes in gut composition, relative abundance and diversity, and Streptococcus abundance	From Week 0, to Week 12
Secondary	Change in Western Ontario and McMaster University Index (WOMAC)	The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.	From Week 0, to Week 12, or to week 24
Secondary	Change in Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).	From Week 0, to Week 12, or to Week 24
Secondary	Change in Medical Outcome 36-Item Short-Form Health Survey	The Medical Outcomes Study 36-Item Short-Form Physical and Mental summary Scores for the quality-of-life components (range, 0 to 100, with higher scores indicating better health status).	From Week 0, to Week 12, or to Week 24
Secondary	Change in Body mass index	Body mass index is measured as the weight (kg) divided by the height (m). squared	From Week 0, to Week 12, or to Week 24