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Safety and Efficacy of Fecal Microbiota Transplantation

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04014413
Enrollment
450
Registered
2019-07-10
Start date
2019-07-15
Completion date
2030-10-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Alopecia, Atopy or Allergy, Autism, Carbapenem-Resistant Enterobacteriaceae Infection, Celiac Disease, Clostridium Difficile Infection, Constipation, Crohn Disease, Diabetes Mellitus, Dysbiotic Bowel Syndrome, Functional Dysphonia, Graft-versus-host Disease, Hepatic Encephalopathy, Idiopathic Thrombocytopenic Purpura, Irritable Bowel Syndrome, Liver Disease, MRSA Enteritis, Multidrug -Resistant Infection, Multiple Organ Dysfunction Syndrome, Multiple Sclerosis, Obesity, Pseudomembranous Enterocolitis, Pseudo-Obstruction, Psoriatic Arthropathy, Ulcerative Colitis, Vancomycin Resistant Enterococci Infection

Brief summary

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. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

Interventions

PROCEDUREFecal Microbiota Transplantation

Fecal microbiota transplantation

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.01 year

Other

MeasureTime frame
Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors1 year

Countries

Hong Kong

Contacts

Primary ContactMatthew Fung
mfung@cuhk.edu.hk+852 35053855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026