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WITHDRAWN
NCT05700331
NA

Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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