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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Participants without chronic pain and depression | ||
| Chronic Widespread Pain participants | Participants with Chronic Widespread Pain |
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| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition | The gut microbiome composition of participants with CWP, as compared with healthy participants | week 1 |
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| 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 |
Inclusion Criteria:
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"
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Fung | Contact | 2609 5050 | +852 | cheryllcfung@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Regina Wing Shan Sit | Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The de-identified stool sample specimens left from this study
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 |
| 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 |
| 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 |