Chronic Widespread PainNCT05678387
Gut Microbiota in Adults With Chronic Widespread Pain
An observational study of Chronic Widespread Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Widespread Pain
- How many people
- 175 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2022to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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"
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Widespread Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Participants without chronic pain and depression | |
| Chronic Widespread Pain participants | Participants with Chronic Widespread Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition
The gut microbiome composition of participants with CWP, as compared with healthy participants
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Wing Shan Sit, Chinese University of Hong Kong
- Investigators
- Regina Wing Shan Sit, Principal investigator, Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678387
- Sponsor's protocol ID
- 2022.469
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota in Adults With Chronic Widespread Pain: a Pilot Case-control Study
- ClinicalTrials.gov ID
- NCT05678387
- Acronym / sponsor ID
- 2022.469
- Conditions
- Chronic Widespread Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | –Participants without chronic pain and depression |
| Chronic Widespread Pain participants | – | –Participants with Chronic Widespread Pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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"
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome composition
Time frame: week 1
The gut microbiome composition of participants with CWP, as compared with healthy participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Wing Shan Sit principal investigator
Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Widespread Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome composition (time frame: week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.