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Pending for funding
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of supplementation of FMT | Adverse events will be monitored throughout the study | through study completion, an average of 1 year |
| Changes in objectively measured pain pressure threshold |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sample (Full blood count) | Not more than 20ml of blood will be collected | Study week 0, 2, 4, 6, 12 |
| Number of participants with With Laboratory Values (Biochemistry profile) | Not more than 20ml of blood will be collected |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Regina Wing Shan Sit, MD | The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D012812 | Sigmoidoscopy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D003113 | Colonoscopy |
| D016099 | Endoscopy, Gastrointestinal |
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|
| 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. |
|
Fischer pressure algometer will be used for measuring pain pressure threshold (PPT).
| 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 | 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 | 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) | 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) | 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 | At baseline, Study week 0 |
| Study week 0, 2, 4, 6, 12 |
| Blood sample (C-reactive protein) | Not more than 20ml of blood will be collected | Study week 0, 2, 4, 6, 12 |
| Stool sample | Stool sample collected through stool sample collection kit with Norgen preservation solutions | Study week 0, 6, 12 |
| D016145 |
| Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |