Chronic Widespread PainNCT05700331
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain
A study testing Fecal Microbiota Transplantation and Sigmoidoscopy in people with Chronic Widespread Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Widespread Pain
- What is being tested?
- Fecal Microbiota Transplantation and Sigmoidoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
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.
Read the 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).
- Conditions
- Chronic Widespread Pain
- Being tested
- Fecal Microbiota Transplantation, Sigmoidoscopy
- Keywords
- Gut Microbiota, Fecal Microbiota Transplantation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
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.
SigmoidoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fecal Microbiota Transplantation; Procedure: Sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Study week 0 , 6 , 12
Secondary outcomes (7)
Safety and tolerability of supplementation of FMT
Adverse events will be monitored throughout the study
Measured: 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).
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: At baseline, Study week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startFeb 2022 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Funding was not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Wing Shan Sit, Chinese University of Hong Kong
- Investigators
- Regina Wing Shan Sit, MD, Principal investigator, The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700331
- Sponsor's protocol ID
- 2022.295
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
- ClinicalTrials.gov ID
- NCT05700331
- Acronym / sponsor ID
- 2022.295
- Conditions
- Chronic Widespread Pain
- Keywords
- Gut Microbiota, Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Widespread Pain patients | Experimental | Procedure: Fecal Microbiota Transplantation, Procedure: Sigmoidoscopy3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationFMT 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. | Procedure or surgery | Chronic Widespread Pain patients |
| SigmoidoscopyOptional 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. | Procedure or surgery | Chronic Widespread Pain patients |
Primary outcome
Changes in self-reported pain severity
Time frame: Study week 0 , 6 , 12
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)
7 secondary outcomes
Safety and tolerability of supplementation of FMT
Time frame: through study completion, an average of 1 year
Changes in objectively measured pain pressure threshold
Time frame: Study week 0 , 6 , 12
Changes in comorbid psychopathology (anxiety symptoms)
Time frame: Study week 0 , 6 , 12
Changes in comorbid psychopathology (depressive symptoms)
Time frame: Study week 0 , 6 , 12
Changes in health-related quality of life
Time frame: Study week 0 , 6 , 12
Changes in Alpha diversity index of gut microbiota
Time frame: Study week 0 , 6 , 12
Sociodemographic data
Time frame: At baseline, Study week 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Wing Shan Sit, MD principal investigator
The Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation and Sigmoidoscopy in people with Chronic Widespread Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported pain severity (time frame: Study week 0 , 6 , 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.