Gut Microbiota in Adults With Chronic Widespread Pain

Last updated: November 6, 2023
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Fibromyalgia

Pain

Treatment

N/A

Clinical Study ID

NCT05678387
2022.469
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 meetthe criteria for CWP, subjects have to report musculoskeletal pain in at least 4 of 5body regions and in at least 3 or more body quadrants (as defined byupper-lower/left-right side of the body) and axial skeleton (neck, back, chest, andabdomen), with pain duration of more than 3 months. A Widespread Pain Index (WPI) willbe generated based on the number of pain sites. Subgroup of patients with fibromyalgiawill be identified according to The American College of Rheumatology 2016 whensubjects WPI of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 4and 6 and an SSS score of ≥ 9.
  2. Healthy Participants Healthy participants will be those without chronic pain and depression. A screeningquestion 'In the past 3 months, have you had pain in your muscles, bones and joints lastingat 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

Exclusion Criteria:

  • Participants with major chronic illnesses, such as malignancy, active inflammatorydiseases, autoimmune diseases and metabolic diseases such as diabetes mellitus andthyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2months, any acute illness in the preceding month, change in regularly taken medicationin the preceding month, and substantial dietary alterations in the preceding month.

Study Design

Total Participants: 240
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2025

Study Description

We aim to identify the variations in gut microbiota composition in Hong Kong adults with CWP. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy control. The design of the study is a pilot case-control study with adults with CWP (n=120) and healthy adults without any chronic pain (n=120). Participants will be recruited in 8 general-outpatient clinics in the New Territories East region of Hong Kong.

Connect with a study center

  • Chinese University of Hong Kong

    Sha Tin,
    Hong Kong

    Active - Recruiting

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