Examining gut microbiota in adults with chronic widespread pain
Gut Microbiota in Adults With Chronic Widespread Pain: a Pilot Case-control Study
This study is looking to see if the gut bacteria in adults with chronic widespread pain are different from those in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Sha Tin) |
| Trial ID | NCT05678387 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the differences in gut microbiota composition between adults suffering from chronic widespread pain (CWP) and healthy individuals. A total of 240 participants will be recruited, including 120 adults with CWP and 120 healthy controls, from general outpatient clinics in the New Territories East region of Hong Kong. Stool samples will be collected and analyzed to determine the variations in microbiota, testing the hypothesis that individuals with CWP have altered gut microbiota compared to healthy subjects.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with chronic widespread pain as defined by specific pain criteria.
Not a fit: Patients without chronic pain or those with other unrelated conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the role of gut microbiota in chronic pain conditions, potentially guiding future therapeutic strategies.
How similar studies have performed: While studies on gut microbiota and pain conditions are emerging, this specific approach focusing on CWP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants with Chronic Widespread pain Participants will be asked, "In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?", as a screening question for CWP. To meet the criteria for CWP, subjects have to report musculoskeletal pain in at least 4 of 5 body regions and in at least 3 or more body quadrants (as defined by upper-lower/left-right side of the body) and axial skeleton (neck, back, chest, and abdomen), with pain duration of more than 3 months. A Widespread Pain Index (WPI) will be generated based on the number of pain sites. Subgroup of patients with fibromyalgia will be identified according to The American College of Rheumatology 2016 when subjects WPI of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 4 and 6 and an SSS score of ≥ 9. 2. Healthy Participants Healthy participants will be those without chronic pain and depression. A screening question 'In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?' will be asked to determine whether participant has chronic pain. Depression status will be determined by the questionnaire "Patient Health Questionnaire-9" Exclusion Criteria: * Participants with major chronic illnesses, such as malignancy, active inflammatory diseases, autoimmune diseases and metabolic diseases such as diabetes mellitus and thyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2 months, any acute illness in the preceding month, change in regularly taken medication in the preceding month, and substantial dietary alterations in the preceding month.
Where this trial is running
Sha Tin
- Chinese University of Hong Kong — Sha Tin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Regina Wing Shan Sit — Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
- Study coordinator: Cheryl Fung
- Email: cheryllcfung@cuhk.edu.hk
- Phone: 2609 5050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.