Using fecal microbiota transplantation to treat gut disorders
Official title: Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
Run by Chinese University of Hong Kong · NCT04014413 · Data updated 2026-11-12
This study is testing whether a treatment that involves using healthy stool to help restore gut bacteria can improve symptoms for people with gut disorders like Crohn's disease and irritable bowel syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hong Kong, Shatin) |
| Status | Recruiting |
| Started | July 15, 2019 |
| Main results expected | October 31, 2030 |
| Study ends | October 31, 2030 |
| Registry record updated | August 22, 2024 |
| Trial ID | NCT04014413 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, or other specified gastrointestinal conditions.
✕Probably not a fit
Patients with conditions not related to gut microbiota dysbiosis or those who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and efficacy of fecal microbiota transplantation (FMT) as a treatment for various gastrointestinal disorders, including Crohn's disease, ulcerative colitis, and irritable bowel syndrome. FMT involves infusing feces from healthy donors into patients to restore a balanced gut microbiota, which is crucial for overall health. The study aims to evaluate the effectiveness of this approach in alleviating symptoms and improving the quality of life for patients suffering from these conditions.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients with chronic gastrointestinal disorders.
How similar studies have gone: Previous studies have shown positive results for fecal microbiota transplantation in treating various gastrointestinal disorders, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The Chinese University of Hong Kong
Hong Kong, Shatin, Hong Kong Recruiting
Study contacts
- Principal investigator: Siew Ng — Chinese University of Hong Kong
- Study coordinator: Matthew Fung
- Email: mfung@cuhk.edu.hk
- Phone: +852 35053855
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.