American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection.
Lawrence J Brandt
https://pubmed.ncbi.nlm.nih.gov/23318479Actively Recruiting
Phase Not Applicable
All Genders
ID04014413
Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
Led by Chinese University of Hong Kong · Updated on 2024-08-22
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of fecal microbiota transplantation (FMT) for various disorders linked to gut microbiota imbalances, known as dysbiosis. These disorders include Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, metabolic syndrome, infections resistant to multiple drugs, and several others. FMT involves transferring feces from healthy donors to patients to restore balanced gut microbiota, and it has shown promise in previous studies for many conditions, though its use in typical clinical settings needs more evaluation. Participants in this study will receive fecal microbiota transplantation. The treatment will be applied across multiple disease groups such as Crohn's disease, ulcerative colitis, diabetes, liver diseases, and infections including multidrug-resistant strains. The transplantation is done through various infusion methods suited to each patient. The study aims to assess FMT's impact on symptoms and monitor any treatment-related side effects over one year. During the study, participants' clinical symptoms will be carefully tracked to measure improvement related to their specific condition. Researchers will also record any adverse events linked to the treatment using standardized criteria. The pilot study is designed to gather comprehensive safety and efficacy data on FMT in real-world clinical practice, with follow-up lasting one year to ensure thorough monitoring and evaluation.
CONDITIONS
Brief Title
Safety and Efficacy of Fecal Microbiota Transplantation
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Crohn's disease
- Confirmed diagnosis of ulcerative colitis
- Confirmed diagnosis of celiac disease
- Confirmed diagnosis of irritable bowel syndrome
- Confirmed diagnosis of functional dyspepsia
- Confirmed diagnosis of constipation
- Antibiotic-associated diarrhea or related antibiotic complications
- Metabolic syndrome including diabetes mellitus and obesity
- Multidrug-resistant infection
- Hepatic encephalopathy
- Multiple sclerosis
- Pseudo-obstruction
- Carbapenem-resistant Enterobacteriaceae or Vancomycin-resistant Enterococci infection
- Multiple organ dysfunction
- Dysbiotic bowel syndrome
- MRSA enteritis
- Pseudomembranous enteritis
- Alopecia or autism
- Graft-versus-host disease
- Idiopathic thrombocytopenic purpura
- Atopy or allergy
- Liver diseases such as Nonalcoholic fatty liver disease and Nonalcoholic steatohepatitis
- Alcohol dependence
- Psoriatic arthropathy with suboptimal disease control despite standard treatment
You will not qualify if you...
- Known contraindication to all fecal microbiota transplant infusion methods such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy, enteroscopy, colonoscopy, and enema
- Any condition that may reduce the efficacy of fecal microbiota transplantation or at investigator discretion
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive fecal microbiota transplantation to treat their condition.
Visits scheduled as needed for treatment and monitoring
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Shatin, Hong Kong, 000000
Actively Recruiting
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Research Team
M
Matthew Fung
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
25
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Published Research Related To This Trial
Healthy Donor Fecal Microbiota Transplantation in Steroid-Ineligible Severe Alcoholic Hepatitis: A Pilot Study.
Cyriac Abby Philips, Apurva Pande, S Murali Shasthry...
https://pubmed.ncbi.nlm.nih.gov/27816755Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.
Sudarshan Paramsothy, Michael A Kamm, Nadeem O Kaakoush...
https://pubmed.ncbi.nlm.nih.gov/28214091Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis.
Noortje G Rossen, Susana Fuentes, Mirjam J van der Spek...
https://pubmed.ncbi.nlm.nih.gov/25836986Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.
Paul Moayyedi, Michael G Surette, Peter T Kim...
https://pubmed.ncbi.nlm.nih.gov/25857665Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial.
Benjamin H Mullish, Julie A K McDonald, Mark R Thursz...
https://pubmed.ncbi.nlm.nih.gov/28714089