Safety and Efficacy of Fecal Microbiota Transplantation
Not applicable · Testing Fecal Microbiota Transplantation · 1 site · Chinese University of Hong Kong
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease, Ulcerative Colitis and Celiac Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- Confirmed diagnosis of any of the following diseases:
- Crohn's disease
- Ulcerative colitis
Plus 22 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 450 participants are expected to take part.
- Start date: 2019-07-15.
- Main results expected around 2030-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Hong Kong.
Main thing being measured
- The efficacy of FMT in treating dysbiosis-associated disorder will be assessed by number of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome) (1 year)
In the researchers’ words
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Ulcerative Colitis; Celiac Disease; Irritable Bowel Syndrome; Functional Dysphonia; Constipation; Clostridium Difficile Infection; Diabetes Mellitus; Obesity; Multidrug -Resistant Infection; Hepatic Encephalopathy; Multiple Sclerosis; Pseudo-Obstruction; Carbapenem-Resistant Enterobacteriaceae Infection; Vancomycin Resistant Enterococci Infection; Multiple Organ Dysfunction Syndrome; Dysbiotic Bowel Syndrome; MRSA Enteritis; Pseudomembranous Enterocolitis; Alopecia; Autism; Graft-versus-host Disease; Idiopathic Thrombocytopenic Purpura; Atopy or Allergy; Liver Disease; Alcohol Dependence; Psoriatic Arthropathy |
| Lead sponsor | Chinese University of Hong Kong |
| Enrollment | 450 (estimated) |
| Start date | 2019-07-15 |
| Primary completion (est.) | 2030-10-31 |
| First posted | 2019-07-10 |
| Last updated | 2024-08-22 |
| Official title | Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study |
| ClinicalTrials.gov ID | NCT04014413 |
Interventions
- Fecal Microbiota Transplantation (Procedure)
Fecal microbiota transplantation
Full eligibility criteria (from the record)
Inclusion Criteria: Confirmed diagnosis of any of the following diseases: * Crohn's disease * Ulcerative colitis * Celiac disease * Irritable bowel syndrome * Functional dyspepsia * Constipation * Antibiotic-associated diarrhea or any antibiotic- associated complications/symptoms * Metabolic syndrome such as diabetes mellitus and obesity * Multidrug-resistant infection * Hepatic encephalopathy * Multiple sclerosis * Pseudo-obstruction * Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection * Multiple organ dysfunction * Dysbiotic bowel syndrome * MRSA enteritis * Pseudomembranous enteritis * Alopecia, autism * Graft-versus-host disease * Idiopathic thrombocytopenic purpura (ITP) * Atopy or allergy * Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH) * Alcohol dependence * Psoriatic arthropathy that has suboptimal control of disease despite standard treatment. Exclusion Criteria: * Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema * Any conditions that may render the efficacy of FMT or at the discretion of the investigators * Current pregnancy
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong, Shatin | Hong Kong | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.