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Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain
Sponsor: Chinese University of Hong Kong
Summary
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.
Official title: Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2022-02
Completion Date
2026-01
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Fecal Microbiota Transplantation
FMT performed at week 0, week-2 and week-4: FMT solution will be prepared using stool from a single donor or mixing of stool from multiple donors. Feces will be diluted with sterile saline (0.9%). This solution will be blended and strained with filter. The resulting supernatant will then be used directly as fresh FMT solution or stored as frozen FMT solution for future FMT. Procedures for Infusion: 100-200 ml of FMT solution or sterile saline will be infused over 2-3 minutes into the distal duodenum or jejunum via oesophago-gastro-duodenoscopy (OGD). After infusion, subjects will be monitored for 1 hour before discharged. 2 study biopsies in total (from duodenum) will be obtained during FMT infusion via OGD.
Sigmoidoscopy
Optional sigmoidoscopy will be done at week 0 and week 4, during which 2 study biopsies in total (obtained via sigmoidoscopy) will be obtained from the rectum.
Locations (1)
Chinese University of Hong Kong
Shatin, Hong Kong