Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

Not Applicable

Suspended

• Conditions: Chronic Widespread Pain
• Interventions: Procedure: Fecal Microbiota Transplantation; Procedure: Sigmoidoscopy

• Registration Number: NCT05700331
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

In this proposed proof-of-concept pilot study, the investigators capitalize an establish chronic pain cohort to explore the effect of FMT in improving the pain symptomology in patients with CWP. This will be a 12-week single-arm prospective interventional study, all study subjects will receive 3 FMT infusions (N =20).

Study Timeline

• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic Widespread Pain patients	Fecal Microbiota Transplantation	3 FMT infusions, 2 weeks apart 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.
Chronic Widespread Pain patients	Sigmoidoscopy	3 FMT infusions, 2 weeks apart 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.

Primary Outcome Measures

Name	Time	Method
Changes in self-reported pain severity	Study week 0 , 6 , 12	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)

Secondary Outcome Measures

Name	Time	Method
Changes in comorbid psychopathology (anxiety symptoms)	Study week 0 , 6 , 12	The Generalized Anxiety Disorder (GAD-7, score range 0-21) will be used to measure anxiety status
Sociodemographic data	At baseline, Study week 0	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
Changes in objectively measured pain pressure threshold	Study week 0 , 6 , 12	Fischer pressure algometer will be used for measuring pain pressure threshold (PPT).
Changes in comorbid psychopathology (depressive symptoms)	Study week 0 , 6 , 12	The Patient Health Questionnaire (PHQ-9, score range 0-27) will be used to measure anxiety status
Changes in health-related quality of life	Study week 0 , 6 , 12	The overall the health-related quality of life (HRQoL) will be measured by the EuroQoul-5 dimensions questionnaire (EQ-5D-5L)
Safety and tolerability of supplementation of FMT	through study completion, an average of 1 year	Adverse events will be monitored throughout the study
Changes in Alpha diversity index of gut microbiota	Study week 0 , 6 , 12	Alpha diversity of the gut microbiome using the Shannon's and inverse Simpson indices will be computed from the operational taxonomic units (OTUs)

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong