Gut Microbiota in Adults With Chronic Widespread Pain

NCT05678387 | Unknown

• 1 other identifier: 2022.469
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to identify the gut microbiome composition in adults with CWP. We will collect the stool sample of 120 healthy individuals and 120 Chronic Widespread Pain patients. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy subjects without CWP.

Conditions

Chronic Widespread Pain

Outcome Measures

Primary Outcomes (1)

• Gut microbiome composition

  The gut microbiome composition of participants with CWP, as compared with healthy participants

  week 1

Other Outcomes (7)

• Depressive status

  At baseline, study week 0

• Dietary intake

  At study week 1

• Bowel habit

  At study week 1

Study Arms (2)

Healthy participants

Participants without chronic pain and depression

Chronic Widespread Pain participants

Participants with Chronic Widespread Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited in 8 general-outpatient clinics in the New Territories East region of Hong Kong. Healthy participants with matching age and sex will be recruited from the general public.

You may qualify if:

• 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.
• 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"

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The de-identified stool sample specimens left from this study

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Regina Wing Shan Sit

  Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Fung

CONTACT

2609 5050; cheryllcfung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Regina Wing Shan SIT

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

HK (1)