Safety and Efficacy of Fecal Microbiota Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Crohn's disease

Ulcerative colitis

Celiac disease

Irritable bowel syndrome

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Microbiota Transplantation

    Procedure/Surgery

    Fecal microbiota transplantation

Treatment groups

450 Participants
are divided into 25 treatment groups

25

Treatment groups

See each treatment group below.

Group A: Crohn's diseaseExperimental treatment 1 intervention
Group B: Ulcerative colitisExperimental treatment 1 intervention
Group C: Celiac diseaseExperimental treatment 1 intervention
Group D: Irritable bowel syndromeExperimental treatment 1 intervention
Group E: Functional dyspepsiaExperimental treatment 1 intervention
Group F: ConstipationExperimental treatment 1 intervention
Group G: Metabolic disease (diabetes mellitus or obesity)Experimental treatment 1 intervention
Group H: Multidrug-resistant infectionExperimental treatment 1 intervention
Group I: Hepatic encephalopathyExperimental treatment 1 intervention
Group J: Multiple sclerosisExperimental treatment 1 intervention
Group K: Pseudo-obstructionExperimental treatment 1 intervention
Group L: CRE infectionExperimental treatment 1 intervention
Group M: VRE infectionExperimental treatment 1 intervention
Group N: Multiple organ dysfunctionExperimental treatment 1 intervention
Group O: Dysbiotic bowel syndromeExperimental treatment 1 intervention
Group P: MRSA enteritisExperimental treatment 1 intervention
Group Q: Pseudomembranous enteritisExperimental treatment 1 intervention
Group R: AlopeciaExperimental treatment 1 intervention
Group S: AutismExperimental treatment 1 intervention
Group T: Graft-versus-host diseaseExperimental treatment 1 intervention
Group U: Idiopathic thrombocytopenic purpuraExperimental treatment 1 intervention
Group V: Atopy or allergyExperimental treatment 1 intervention
Group W: Liver diseaseExperimental treatment 1 intervention
Group X: Alcohol dependenceExperimental treatment 1 intervention
Group Y: Antibiotic-associated diarrheaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
1 year

Secondary outcomes

1

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time frame
1 year

Other outcomes

1

Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors

Time frame
1 year

Sponsors and contacts

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