Chronic Widespread Pain Clinical Trial
Official title:
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
NCT number | NCT05700331 |
Other study ID # | 2022.295 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2025 |
Est. completion date | January 2026 |
Verified date | August 2023 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to explore the effect of Fecal Microbiota Transplantation (FMT) on the clinical symptomatology in Chronic Widespread Pain (CWP), to assess the acceptability, tolerability, and safety of FMT in patients with CWP, as well as explore the effect of FMT on the gut microbiome diversity in CWP. The investigators hypothesize that fecal microbiota transplantation will reduce pain intensity in patients with CWP, is acceptable, safe, and tolerable in patients with CWP, and will achieve change of gut microbiome diversity after FMT treatment.
Status | Suspended |
Enrollment | 20 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Participants aged = 18 with diagnosis CWP; A modified version of the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) will be used to screen for the presence of CWP. Exclusion Criteria: - Patients with fibromyalgia, a subgroup with complex neurobiological, behavioural and psychological factors on its pathogenesis, will be excluded.[8] This 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. - Patients have a history of inflammatory bowel disease or gastrointestinal malignancy - Patients have previous abdominal surgery (other than cholecystectomy or appendectomy) - Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score > 15 - Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score > 10 - Patients have active infection at the time of inclusion - Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days - Patients have any other organic causes that can explain the symptoms of CWP - Current pregnancy - Confirmed current active malignancy or cancers - Pregnancy test negative for all female patients of child-bearing potential (except postmenopausal patients and sterilized patients). |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Chinese University of Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood sample (Full blood count) | Not more than 20ml of blood will be collected | Study week 0, 2, 4, 6, 12 | |
Other | Number of participants with With Laboratory Values (Biochemistry profile) | Not more than 20ml of blood will be collected | Study week 0, 2, 4, 6, 12 | |
Other | Blood sample (C-reactive protein) | Not more than 20ml of blood will be collected | Study week 0, 2, 4, 6, 12 | |
Other | Stool sample | Stool sample collected through stool sample collection kit with Norgen preservation solutions | Study week 0, 6, 12 | |
Primary | Changes in self-reported pain severity | Pain severity will be measured by Brief Pain Inventory (BPI), which consists of 4-item severity and 7-item interference subscale scores (Score range 0-10) | Study week 0 , 6 , 12 | |
Secondary | Safety and tolerability of supplementation of FMT | Adverse events will be monitored throughout the study | through study completion, an average of 1 year | |
Secondary | Changes in objectively measured pain pressure threshold | Fischer pressure algometer will be used for measuring pain pressure threshold (PPT). | Study week 0 , 6 , 12 | |
Secondary | Changes in comorbid psychopathology (anxiety symptoms) | The Generalized Anxiety Disorder (GAD-7, score range 0-21) will be used to measure anxiety status | Study week 0 , 6 , 12 | |
Secondary | Changes in comorbid psychopathology (depressive symptoms) | The Patient Health Questionnaire (PHQ-9, score range 0-27) will be used to measure anxiety status | Study week 0 , 6 , 12 | |
Secondary | Changes in health-related quality of life | The overall the health-related quality of life (HRQoL) will be measured by the EuroQoul-5 dimensions questionnaire (EQ-5D-5L) | Study week 0 , 6 , 12 | |
Secondary | Changes in Alpha diversity index of gut microbiota | Alpha diversity of the gut microbiome using the Shannon's and inverse Simpson indices will be computed from the operational taxonomic units (OTUs) | Study week 0 , 6 , 12 | |
Secondary | Sociodemographic data | Demographics and medical history such as sex, age, smoking and alcohol status, disease onset, co-morbid illness, drug history, clinical test results will be obtained by reviewing of patient medical notes and interview with patients by doctors and research staff | At baseline, Study week 0 |
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