Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

NCT05700331 | Suspended

• 1 other identifier: 2022.295
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Widespread Pain

Keywords

Gut Microbiota; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Safety and tolerability of supplementation of FMT

  through study completion, an average of 1 year

• Changes in objectively measured pain pressure threshold

  Study week 0 , 6 , 12

• Changes in comorbid psychopathology (anxiety symptoms)

  Study week 0 , 6 , 12

• Changes in comorbid psychopathology (depressive symptoms)

  Study week 0 , 6 , 12

• Changes in health-related quality of life

  Study week 0 , 6 , 12

Other Outcomes (4)

• Blood sample (Full blood count)

  Study week 0, 2, 4, 6, 12

• Number of participants with With Laboratory Values (Biochemistry profile)

  Study week 0, 2, 4, 6, 12

• Blood sample (C-reactive protein)

  Study week 0, 2, 4, 6, 12

Study Arms (1)

Chronic Widespread Pain patients

EXPERIMENTAL

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.

Procedure: Fecal Microbiota Transplantation; Procedure: Sigmoidoscopy

Interventions

Fecal Microbiota Transplantation PROCEDURE

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.

Chronic Widespread Pain patients

Sigmoidoscopy PROCEDURE

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.

Chronic Widespread Pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Fecal Microbiota Transplantation; Sigmoidoscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Regina Wing Shan Sit, MD

  The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Regina Wing Shan SIT

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 26, 2023
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)