A Phase 2 interventional study of Fecal Microbiota Transplant (FMT) oral capsules and Placebo oral capsule in Hepatic Encephalopathy, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
Among 69 studies in Hepatic Encephalopathy with a site in United States — 8 open to participants now, 12 under way, 1 of them phase 3. Hepatic Encephalopathy · United States.
Among the 69 studies in Hepatic Encephalopathy with a site in United States, this one is the 32nd largest by planned enrollment of the 57 interventional ones, is one of 6 that started in 2018, is one of 18 in phase 2, reaches primary completion later than 5 of the 11 other live ones, and was the 34th registered.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →8 of the 69 studies in Hepatic Encephalopathy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 29 Hepatic Encephalopathy studies recruiting now, 11 (38%) set no upper age limit and 13 (45%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →69 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 6 started in 2018.
Median enrollment 37 across the 57 interventional studies, 38 across the 12 observational. Of the 48 that completed or were terminated, 19 (40%) have results posted.
17 of 69 have an industry lead sponsor. The 10 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Massachusetts General Hospital has 1 study filed under Hepatic Encephalopathy — fewer than ten, so there is no comparison to draw.
5 of the studies in Hepatic Encephalopathy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03420482Massachusetts General HospitalFecal Microbiota Transplant as Treatment of Hepatic Encephalopathy | 2026-12-31 |
| NCT07046429Weill Medical College of Cornell UniversityAffect of Melatonin on Sleep and Cognition in Cirrhosis | 2026-12-31 |
| NCT06425380Mayo ClinicPilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy | 2027-01-28 |
| NCT04096014The Cleveland ClinicLate Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy | 2027-06-30 |
| NCT07553858Rutgers, The State University of New JerseyEndoscopic Shunts Embolization for Refractory Hepatic Encephalopathy | 2027-11-01 |
Among the 69 studies in Hepatic Encephalopathy with a site in United States, from their registry updates:
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.
Decades of investigation demonstrate that hepatic encephalopathy (HE), a common complication of cirrhosis characterized by impaired cognition, develops as a consequence of intestinal microbial products reaching the brain. Recent investigation has found that cirrhotic patients, especially those who have developed HE, have intestinal dysbiosis compared to normal controls. Several plausible mechanisms explain how intestinal dysbiosis could lead to HE. There is limited prior literature on the efficacy of FMT in cirrhosis. The largest documented study of 10 cirrhotic patients receiving a single FMT enema found no significant change in microbiome diversity as assessed by 16S rRNA sequencing. The investigators hypothesize that aggressive manipulation of the microbial composition with fecal microbiota transplant (FMT) will improve neurological function in patients with a history of cirrhosis and HE. The investigators additionally hypothesize that five oral FMT capsule administrations from a previously efficacious stool donor will significantly change the intestinal microbiome composition of a cirrhotic patient. The study will consist of a 10-patient open-label pilot study to identify efficacious stool donors, defined as donors who precipitate the largest improvement in recipient neurological function and microbiome composition. The two most efficacious pilot study stool donors will be selected to donate stool for the randomized controlled trial (RCT). The 20-patient RCT will investigate the effect of FMT on neurological outcomes in patients with cirrhosis and a history of HE. Subjects will be randomized to receive 5 doses of oral FMT capsules or placebo capsules over 21 days. Cognitive testing and stool collections will occur at 4 time points, to assess for changes in neurological function and microbiome composition. The primary outcome is change in neurological function after FMT. The main secondary outcome is change in microbiome composition after FMT. This study could provide valuable information about the ability of FMT to improve intestinal dysbiosis in cirrhosis and treat HE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 15 oral capsules of FMT on days 1, 2, 7, 14, and 21.
Drug: Fecal Microbiota Transplant (FMT) oral capsules
Subjects will receive placebo capsules on the same schedule as the experimental arm (days 1, 2, 7, 14, and 21).
Drug: Placebo oral capsule
Donors will be healthy individuals, selected through a previously published, rigorous screening process. Elizabeth Hohmann M.D. of MGH has demonstrated the safety and therapeutic efficacy of oral frozen FMT capsules in Clostridium difficile infection, and her lab will produce the capsules for this study.
Oral placebo capsules filled with glycerol and cocoa powder. These capsules are identical in appearance to FMT capsules.
Psychometric Hepatic Encephalopathy Score (PHES)
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.
Time frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
Adverse events
Adverse events will be graded based on CTCAE V.4.03.
Time frame: Adverse event reporting will take place on day 2, 4, 7, 14, 21, then 1, 4 weeks after the last FMT administration.
Stroop Test
The Stroop Test evaluates psychomotor speed and cognitive flexibility by the interference between recognition reaction time to a colored field and a written color name. A smartphone application software called "EncephalApp Stroop Test" will be used, validated to identify cognitive dysfunction in cirrhosis and screen for covert hepatic encephalopathy.
Time frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
36-Item Short Form Health Survey (SF-36)
The SF-36 is a highly utilized quality of life questionnaire. There are 8 health concepts assessed by the survey, which includes physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each of these health concepts is scored on a scale from 0 to 100. 0 is considered the worst outcome and 100 is considered the most favorable health state on each subscale. There will be no total or summed score.
Time frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
Ammonia level
Ammonia is a serology with a known association with hepatic encephalopathy.
Time frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
Microbiome engraftment
Sequence-based microbiome surveys will be carried out using metagenomic sequencing. Computational analyses will investigate donor microbiota colonization by comparing single-nucleotide variants in strain level data between the donor and recipient.
Time frame: Before the first administration of FMT (day 0), after 3 FMT administrations (day 14), one week after the last administration of FMT (day 28) and 4 weeks after the last administration of FMT.
Started Apr 2018 (actual). Primary completion is estimated for Dec 2026, 104 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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