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Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

Primary Purpose

Chronic Widespread Pain

Status
Suspended
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sigmoidoscopy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Widespread Pain focused on measuring Gut Microbiota, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic Widespread Pain patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2022
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05700331
Brief Title
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain
Official Title
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Pending for funding
Study Start Date
January 2025 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Widespread Pain
Keywords
Gut Microbiota, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic Widespread Pain patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sigmoidoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in self-reported pain severity
Description
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)
Time Frame
Study week 0 , 6 , 12
Secondary Outcome Measure Information:
Title
Safety and tolerability of supplementation of FMT
Description
Adverse events will be monitored throughout the study
Time Frame
through study completion, an average of 1 year
Title
Changes in objectively measured pain pressure threshold
Description
Fischer pressure algometer will be used for measuring pain pressure threshold (PPT).
Time Frame
Study week 0 , 6 , 12
Title
Changes in comorbid psychopathology (anxiety symptoms)
Description
The Generalized Anxiety Disorder (GAD-7, score range 0-21) will be used to measure anxiety status
Time Frame
Study week 0 , 6 , 12
Title
Changes in comorbid psychopathology (depressive symptoms)
Description
The Patient Health Questionnaire (PHQ-9, score range 0-27) will be used to measure anxiety status
Time Frame
Study week 0 , 6 , 12
Title
Changes in health-related quality of life
Description
The overall the health-related quality of life (HRQoL) will be measured by the EuroQoul-5 dimensions questionnaire (EQ-5D-5L)
Time Frame
Study week 0 , 6 , 12
Title
Changes in Alpha diversity index of gut microbiota
Description
Alpha diversity of the gut microbiome using the Shannon's and inverse Simpson indices will be computed from the operational taxonomic units (OTUs)
Time Frame
Study week 0 , 6 , 12
Title
Sociodemographic data
Description
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
Time Frame
At baseline, Study week 0
Other Pre-specified Outcome Measures:
Title
Blood sample (Full blood count)
Description
Not more than 20ml of blood will be collected
Time Frame
Study week 0, 2, 4, 6, 12
Title
Number of participants with With Laboratory Values (Biochemistry profile)
Description
Not more than 20ml of blood will be collected
Time Frame
Study week 0, 2, 4, 6, 12
Title
Blood sample (C-reactive protein)
Description
Not more than 20ml of blood will be collected
Time Frame
Study week 0, 2, 4, 6, 12
Title
Stool sample
Description
Stool sample collected through stool sample collection kit with Norgen preservation solutions
Time Frame
Study week 0, 6, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina Wing Shan Sit, MD
Organizational Affiliation
The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

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Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

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