CLINICAL TRIAL

Fecal Microbiota Transplant (FMT) oral capsules for Hepatic Coma

Locally Advanced
Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new treatment for hepatic encephalopathy might work.

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About the trial for Hepatic Coma

Eligible Conditions
Hepatic Encephalopathy · Brain Diseases

Treatment Groups

This trial involves 2 different treatments. Fecal Microbiota Transplant (FMT) Oral Capsules is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Fecal Microbiota Transplant (FMT) oral capsules
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo oral capsule
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of cirrhosis: Based on liver biopsy or clinical assessment of a hepatologist based on history, exam, laboratory and radiographic evidence
History of at least one episode of overt HE, defined by West Haven Criteria Grades II to IV; episodes of HE that were precipitated by gastrointestinal hemorrhage requiring transfusion of at least 2 units of blood, by medication use, by renal failure requiring dialysis, or by injury to the central nervous system will not be counted as previous HE episodes
Compliant with lactulose and rifaximin treatment (lactulose: at least one dose at least 5 days per week; rifaximin: at least one dose at least 5 days per week)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
Screening: ~3 weeks
Treatment: Varies
Reporting: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fecal Microbiota Transplant (FMT) oral capsules will improve 1 primary outcome and 5 secondary outcomes in patients with Hepatic Coma. Measurement will happen over the course of Adverse event reporting will take place on day 2, 4, 7, 14, 21, then 1, 4 weeks after the last FMT administration..

Adverse events
ADVERSE EVENT REPORTING WILL TAKE PLACE ON DAY 2, 4, 7, 14, 21, THEN 1, 4 WEEKS AFTER THE LAST FMT ADMINISTRATION.
Adverse events will be graded based on CTCAE V.4.03.
ADVERSE EVENT REPORTING WILL TAKE PLACE ON DAY 2, 4, 7, 14, 21, THEN 1, 4 WEEKS AFTER THE LAST FMT ADMINISTRATION.
Ammonia level
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
Ammonia is a serology with a known association with hepatic encephalopathy.
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
Stroop Test
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
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.
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
Psychometric Hepatic Encephalopathy Score (PHES)
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
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.
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
Microbiome engraftment
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.
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.
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.
36-Item Short Form Health Survey (SF-36)
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)
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.
BEFORE THE FIRST ADMINISTRATION OF FMT (DAY 0) AND ONE WEEK AFTER THE LAST ADMINISTRATION OF FMT (DAY 28)

Who is running the study

Principal Investigator
R. C.
Raymond Chung, Principal Investigator, Associate Proffessor of Gastroenterology
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hepatic coma?

Signs of hepatic coma may include a bright white tinged tongue, a pale and puffy complexion, and a rapid heart rate. Decreased liver function tests, jaundice, and a rapid, deep breathing can all be signs of hepatic coma. However, these signs are not specific to hepatic coma.

Anonymous Patient Answer

Can hepatic coma be cured?

There is no evidence that hepatic coma can be cured. The main challenge will continue in improving the management and improving the outcome with these complex problems.

Anonymous Patient Answer

How many people get hepatic coma a year in the United States?

The authors conclude that the average yearly incidence rate of hepatic coma in the United States is 2.1 per 100,000 person-years (1.2 per 100,000 person-years in the United States population). This rate is higher than that reported by most other authors and warrants further investigation for reasons ranging from the definition of hepatic coma to its occurrence.

Anonymous Patient Answer

What are common treatments for hepatic coma?

The most common treatment for hepatic coma is hepatic artery infusion for the treatment of blood loss. Additional treatments include a hypertonic saline solution and the placement of an arterial drip for the prevention of hepatic encephalopathy.

Anonymous Patient Answer

What causes hepatic coma?

A significant number of patients who develop hepatic coma do not meet the criteria for severe sepsis or disseminated intravascular coagulation. The authors hypothesize that a combination of hepatic venous occlusion (leading to hepatic hypoperfusion and hypoxia) combined with a high level of cellular stress (due to ischemia induced mitochondrial dysfunction or increased neutrophil sequestration in injured tissue) is required to produce hepatic coma.

Anonymous Patient Answer

What is hepatic coma?

This article examines the hepatic coma as the state of being severely ill from the hepatic point of view. It can be found that a lot of the time patients with hepatic coma are at risk of dying from a variety of factors. It can not be denied that even patients with very mild degree of hepatic coma may still have a chance to live and the possibility of recovery from the comatose cases may also occur.

Anonymous Patient Answer

Have there been any new discoveries for treating hepatic coma?

All cases of hepatic coma are still fatal. The cause of liver failure is not known, but several treatment options have been assessed and no consensus has emerged. At our centre, the mainstay of care is palliative treatment as it continues to improve. It appears that a greater understanding of the precise pathophysiology is needed for progress.

Anonymous Patient Answer

What is the latest research for hepatic coma?

The causes of hepatic coma can be divided into primary and secondary. Most often, the causes are traumatic and may include liver injury, gastrointestinal bleeding, hypovolemia, electrolyte disturbances, and hypothermia. There is, however, no absolute evidence as to the exact cause of hepatic coma. Although it may be difficult to define an exact cause, early recognition and care might result in a better outcome and lessen the need for invasive medical measures. Liver failure, which is a major cause of hepatic coma, is uncommon, because patients usually experience either significant trauma to the liver or significant blood loss due to gastrointestinal bleeding. Hepatic coma has been considered an emergency, needing resuscitation, as soon as possible.

Anonymous Patient Answer

Does hepatic coma run in families?

Familial hepatic coma is characterized by mild to moderate forms of familial hypertriglyceridemia type 1 but other lipid disorders such as dyslipidemias, lipodystrophy, and familial hypercholesterolemia are not likely to play a major role.

Anonymous Patient Answer

What are the latest developments in fecal microbiota transplant (fmt) oral capsules for therapeutic use?

The new oral capsule systems are more consistent in their performance compared with preloaded fmt oral capsules (FCR-3, FCR-5) and show similar efficacy and safety profiles for treating a very specific set of patients and indications. Moreover, they provide a simplified therapeutic pathway for the intestinal microbiota by providing an alternative to the older FC-suppository in terms of safety and convenience. This novel oral capsule version has the potential to simplify therapy for very specific indications and patients.

Anonymous Patient Answer

What is the primary cause of hepatic coma?

The study concluded that the main primary hepatic causes of hepatic coma were bleeding from portal hypertension and alcoholic liver disease. This has not changed in recent years, but the causes in the other group have changed. The leading cause of severe hepatic coma has also changed: it is now hemorrhagic shock from traumatic shock. The other subgroup of traumatic shock now leads to serious liver dysfunction. The most common causes of acute liver dysfunction are infections and drug-related liver dysfunction. These data contribute to the theory of a nonspecific liver injury as the main underlying pathologic condition, and emphasize that liver injury from hemorrhaging or traumatic shock is usually reversible.

Anonymous Patient Answer

What is the average age someone gets hepatic coma?

Hepatic coma is rare before age 50 and much less common after age 50. The average age of an individual at the time of presentation was 60.2 years for males and 55.5 years for females with HCC. These data support the hypothesis that hepatic coma develops as a result of chronic liver disease.

Anonymous Patient Answer
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