Poop pills could clear brain fog in liver disease
NCT ID NCT03420482
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether transplanting healthy gut bacteria from donors can improve confusion in people with advanced liver disease. Thirty participants will receive either fecal transplant capsules or a placebo. The goal is to see if this approach can safely improve thinking and reduce side effects compared to current treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal microbiota transplant (FMT) oral capsules
- What this could lead to
- If it works, this could offer a new, safer treatment for confusion caused by liver disease by restoring healthy gut bacteria.
- What could go wrong
- This is a small, early-phase trial with only 30 participants. The treatment may not work better than placebo, and there are risks of infection or side effects from the transplant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2018
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * Current episode of overt HE as defined by West Haven Criteria Grades II to IV * Expectation of liver transplantation within two months of the screening visit * Current infection * Variceal bleeding in the last 4 weeks * Gut-absorbable or intravenous antibiotic therapy (including ciprofloxacin for SBP prophylaxis) in the last 3 months * Alcohol or illicit drug intake within 3 months, by history and available serum testing; alcohol use will be characterized as \>1 alcoholic drink / month * PSC as etiology of liver disease, as prior literature has suggested these individuals have a unique microbiome * History of Roux-en-Y Gastric bypass * On immunosuppressive medications * Positive C. difficile test * Scoring above a threshold cut-off on the Psychometric Hepatic Encephalopathy Score (PHES) * MELD \> 17 * History of spontaneous bacterial peritonitis * History of low ascites protein ( ≤ 1g/dL) in the last year * Hemodialysis in the last 30 days * Other significant laboratory abnormalities: serum creatinine \> 2.0 mg/dL, hemoglobin \< 8 g/dL, serum sodium \< 125 mmol/L, serum calcium \> 11.0 mg/dL, serum potassium \< 2.5 mmol/L * Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt * Unstable doses of opiates, benzodiazepines or other sedating medication * Unable to provide consent; a. If MMSE is \< 18 or the patient is deemed to not have capacity by an investigator, a legally authorized representative (surrogate) will be allowed to provide consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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