Gut Microbiota in Adults With Chronic Widespread Pain

Chronic Widespread Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678387
• Other study ID #: 2022.469
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Cheryl Fung
• Phone: 2609 5050
• Email: cheryllcfung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Widespread Pain

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Physical activity level	Physical activity will be assessed by the Chinese version of International Physical Activity Questionnaire (IPAQ) short form.	At study week 1
Other	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
Other	Sociodemographic data	Sociodemographic information such as age and sex, comorbid diseases, lifestyle habits (smoking and drinking status)	At baseline, study week 0
Other	BMI		At baseline, study week 0
Primary	Gut microbiome composition	The gut microbiome composition of participants with CWP, as compared with healthy participants	week 1