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NCT03420482 · ClinicalTrials.gov registry record · Phase 2
Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy
A Phase 2 study of Hepatic Encephalopathy, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03420482: Active Phase 2 study of Hepatic Encephalopathy, sponsored by Massachusetts General Hospital.
NCT03420482 is a Phase 2 study of Hepatic Encephalopathy that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 174-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03420482, a Phase 2 study of Hepatic Encephalopathy, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
A common complication of advanced liver disease is a condition called hepatic encephalopathy, which leads to confusion. The current treatment options cause side effects, are costly, and do not always work. An abnormal population of bacteria in the intestines may be causing this condition, and transplanting bacteria from the colon of a healthy person may treat it. In this research study, the investigators will first find two healthy stool donors whose stool donation improves the gut bacteria of patients with advanced liver disease and helps them think more clearly. Then, in a randomized controlled trial, the investigators will compare the ability of stool donation from these two best donors versus a placebo to improve the neurological function of patients with advanced liver disease. If the investigators find the expected results, there will be a new effective therapy for patients with advanced liver disease and the very troublesome complication of hepatic encephalopathy.
Primary Outcome
The PHES is a validated assessment tool specifically designed for HE trials to test cognitive and psychomotor processing speed and visuomotor coordination. The PHES is a battery of 5 pencil-paper tests, completed in 15-20 minutes. The primary outcome is the change in PHES score from immediately before FMT to 1 week after the last dose of FMT.
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Fecal Microbiota Transplant (FMT) oral capsules
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
What the registry record for NCT03420482 still lists
NCT03420482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 174-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Hepatic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03420482 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03420482 about?
NCT03420482 is a clinical study titled "Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy". A common complication of advanced liver disease is a condition called hepatic encephalopathy, which leads to confusion. The current treatment options cause side effects, are costly, and do not always work. An abnormal population of bacteria in the intestines may be causing this condition, and transp...
What is the current status of trial NCT03420482?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-04-01. Estimated completion is 2027-01-31.
What conditions does trial NCT03420482 study?
This clinical trial studies the following conditions: Hepatic Encephalopathy.
What interventions are being tested in trial NCT03420482?
The interventions under investigation include: Placebo oral capsule (DRUG), Fecal Microbiota Transplant (FMT) oral capsules (DRUG).
Who is sponsoring clinical trial NCT03420482?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03420482 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03420482's enrollment target sits among peer trials
30 10th of 12 higher than 2 of 12 other Hepatic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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