Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Who is this study for? Patients with Crohn's Disease, Ulcerative Colitis, Celiac Disease, or other Bowel Disorders
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Matthew Fung
mfung@cuhk.edu.hk
+852 35053855
Time Frame
Start Date: 2019-07-15
Estimated Completion Date: 2030-10-31
Participants
Target number of participants: 450
Treatments
Experimental: Crohn's disease
Fecal Microbiota Transplant will be performed.
Experimental: Ulcerative colitis
Fecal Microbiota Transplant will be performed.
Experimental: Celiac disease
Fecal Microbiota Transplant will be performed.
Experimental: Irritable bowel syndrome
Fecal Microbiota Transplant will be performed.
Experimental: Functional dyspepsia
Fecal Microbiota Transplant will be performed.
Experimental: Constipation
Fecal Microbiota Transplant will be performed.
Experimental: Metabolic disease (diabetes mellitus or obesity)
Fecal Microbiota Transplant will be performed.
Experimental: Multidrug-resistant infection
Fecal Microbiota Transplant will be performed.
Experimental: Hepatic encephalopathy
Fecal Microbiota Transplant will be performed.
Experimental: Multiple sclerosis
Fecal Microbiota Transplant will be performed.
Experimental: Pseudo-obstruction
Fecal Microbiota Transplant will be performed.
Experimental: CRE infection
Fecal Microbiota Transplant will be performed.
Experimental: VRE infection
Fecal Microbiota Transplant will be performed.
Experimental: Multiple organ dysfunction
Fecal Microbiota Transplant will be performed.
Experimental: Dysbiotic bowel syndrome
Fecal Microbiota Transplant will be performed.
Experimental: MRSA enteritis
Fecal Microbiota Transplant will be performed.
Experimental: Pseudomembranous enteritis
Fecal Microbiota Transplant will be performed.
Experimental: Alopecia
Fecal Microbiota Transplant will be performed.
Experimental: Autism
Fecal Microbiota Transplant will be performed.
Experimental: Graft-versus-host disease
Fecal Microbiota Transplant will be performed.
Experimental: Idiopathic thrombocytopenic purpura
Fecal Microbiota Transplant will be performed.
Experimental: Atopy or allergy
Fecal Microbiota Transplant will be performed.
Experimental: Liver disease
Fecal Microbiota Transplant will be performed.
Experimental: Alcohol dependence
Fecal Microbiota Transplant will be performed.
Experimental: Antibiotic-associated diarrhea
Fecal Microbiota Transplant will be performed.
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov

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