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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for not_applicable

Timeline

55mo left

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.3 years study duration

Study Progress60%

Jul 2019Oct 2030

First Submitted

Initial submission to the registry

June 21, 2019

Completed

19 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed

5 days until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed

11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2030

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

11.3 years

First QC Date

June 21, 2019

Last Update Submit

August 21, 2024

Outcome Measures

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)
1 year

Secondary Outcomes (1)

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

Other Outcomes (1)

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