Clinical trial NCT05700331: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Widespread Pain
Keywords: Gut Microbiota
Fecal Microbiota Transplantation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Changes in self-reported pain severity
timeFrame: Study week 0 , 6 , 12
Secondary outcomes:
measure: Safety and tolerability of supplementation of FMT
timeFrame: through study completion, an average of 1 year
measure: Changes in objectively measured pain pressure threshold
timeFrame: Study week 0 , 6 , 12
measure: Changes in comorbid psychopathology (anxiety symptoms)
timeFrame: Study week 0 , 6 , 12
measure: Changes in comorbid psychopathology (depressive symptoms)
timeFrame: Study week 0 , 6 , 12
measure: Changes in health-related quality of life
timeFrame: Study week 0 , 6 , 12
measure: Changes in Alpha diversity index of gut microbiota
timeFrame: Study week 0 , 6 , 12
measure: Sociodemographic data
timeFrame: At baseline, Study week 0
Other outcomes:
measure: Blood sample (Full blood count)
timeFrame: Study week 0, 2, 4, 6, 12
measure: Number of participants with With Laboratory Values (Biochemistry profile)
timeFrame: Study week 0, 2, 4, 6, 12
measure: Blood sample (C-reactive protein)
timeFrame: Study week 0, 2, 4, 6, 12
measure: Stool sample
timeFrame: Study week 0, 6, 12
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
name: Regina Wing Shan Sit, MD
role: PRINCIPAL_INVESTIGATOR
References: