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NCT05678387
Gut Microbiota in Adults With Chronic Widespread Pain
Conditions: Chronic Widespread Pain
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Chinese University of Hong Kong
Location: Hong Kong
Summary
We aim to identify the gut microbiome composition in adults with CWP.
We will collect the stool sample of 50 healthy individuals and 50 Chronic Widespread Pain patients.
We hypothesize that the intestinal microbiota is altered in CWP compared to healthy subjects without CWP.
Eligibility Criteria
Inclusion Criteria:Participants with Chronic Widespread painA modified version of the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) will be used to screen for the presence of CWP.
Those who answered yes to the question 'In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?' will receive a more detailed paper questionnaire, with questions adapted from the LFESSQ.
The questionnaire contained questions about musculoskeletal pain lasting >1 week in the right or left shoulders, arms or hands, in the right or left legs or feet, and in the neck, chest or back.
A pain map will be provided to assist locating the pain region.
Participants will also be asked whether the pain has lasted >3 months.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.Healthy ParticipantsHealthy 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 Fibromyalgia, screening will be based on The American College of Rheumatology 2010 when subjects with CWP but with a widespread pain index (WPI) of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 3 and 6 and an SSS score of ≥ 9.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.
Source: ClinicalTrials.gov (NCT05678387). StuddyBuddy aggregates publicly available trial information.