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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
Chinese University of Hong Kong
Shatin, Hong Kong
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)
Time frame: Study week 0 , 6 , 12
Safety and tolerability of supplementation of FMT
Adverse events will be monitored throughout the study
Time frame: through study completion, an average of 1 year
Changes in objectively measured pain pressure threshold
Fischer pressure algometer will be used for measuring pain pressure threshold (PPT).
Time frame: Study week 0 , 6 , 12
Changes in comorbid psychopathology (anxiety symptoms)
The Generalized Anxiety Disorder (GAD-7, score range 0-21) will be used to measure anxiety status
Time frame: Study week 0 , 6 , 12
Changes in comorbid psychopathology (depressive symptoms)
The Patient Health Questionnaire (PHQ-9, score range 0-27) will be used to measure anxiety status
Time frame: Study week 0 , 6 , 12
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)
Time frame: Study week 0 , 6 , 12
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)
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Time frame: Study week 0 , 6 , 12
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
Time frame: At baseline, Study week 0