Using fecal microbiota transplantation to treat gut disorders
Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
NA · Chinese University of Hong Kong · NCT04014413
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hong Kong, Shatin) |
| Trial ID | NCT04014413 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, or other specified gastrointestinal conditions.
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.
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 performed: Previous studies have shown positive results for fecal microbiota transplantation in treating various gastrointestinal disorders, indicating a promising approach.
Eligibility criteria
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 this trial is running
Hong Kong, Shatin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel Syndrome, Functional Dysphonia, Constipation, Clostridium Difficile Infection, Diabetes Mellitus