Skip to content

Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

SuspendedNot applicableNCT05700331
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
Interventions
  • Procedure: Fecal Microbiota Transplantation
  • Procedure: Sigmoidoscopy
Sponsor
Chinese University of Hong Kong
Start date
2025-01
Primary completion
2026-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Hong Kong
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05700331