Gut Microbiota in Adults With Chronic Widespread Pain

Gut Microbiota in Adults With Chronic Widespread Pain: a Pilot Case-control Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Widespread Pain

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Cheryl Fung; Phone Number: +852 2609 5050; Email: cheryllcfung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Cheryl Fung; Phone Number: +852 2609 5050; Email: cheryllcfung@cuhk.edu.hk
    • Principal Investigator: Regina Wing Shan Sit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy participants; Participants without chronic pain and depression
Chronic Widespread Pain participants; Participants with Chronic Widespread Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome composition	The gut microbiome composition of participants with CWP, as compared with healthy participants	week 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive status	The depressive status of participants will be assessed by the Patient Health Questionnaire (PHQ-9), a 9-item self-reported measures to diagnose and assess the severity of depression.	At baseline, study week 0
Dietary intake	Dietary intake will be assessed by the Hong Kong Diet Score (HKDS), a 9-item diet screener, based on Mediterranean Diet Score (MDS) cutoff values and Hong Kong Chinese food consumption reported by the government.	At study week 1
Physical activity level	Physical activity will be assessed by the Chinese version of International Physical Activity Questionnaire (IPAQ) short form.	At study week 1
Use of Chronic medications	The use of chronic medications will be enquired from participants and further confirmed with hospital electronic system.	At baseline, study week 0
Sociodemographic data	Sociodemographic information such as age and sex, comorbid diseases, lifestyle habits (smoking and drinking status)	At baseline, study week 0
BMI		At baseline, study week 0
Bowel habit	Bowel habit will be assessed by the Bristol Stool Scale (BSS), a validated measure of intestinal transit that categorizes stool into 7 types from type 1 (hard lumps) to type 7 (watery diarrhea)	At study week 1

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Regina Wing Shan Sit, Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2022.469

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No