Clinical trial NCT05678387: Gut Microbiota in Adults With Chronic Widespread Pain
Official title: Gut Microbiota in Adults With Chronic Widespread Pain: a Pilot Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Widespread Pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiome composition
timeFrame: week 1
Secondary outcomes:
Other outcomes:
measure: Depressive status
timeFrame: At baseline, study week 0
measure: Dietary intake
timeFrame: At study week 1
measure: Bowel habit
timeFrame: At study week 1
measure: Physical activity level
timeFrame: At study week 1
measure: Use of Chronic medications
timeFrame: At baseline, study week 0
measure: Sociodemographic data
timeFrame: At baseline, study week 0
measure: BMI
timeFrame: At baseline, study week 0
Locations:
city: Sha Tin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
name: Regina Wing Shan Sit
role: PRINCIPAL_INVESTIGATOR
References: