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Tests treatment safety and results for Alcoholic Hepatitis
Official title Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
ClinicalTrials.gov ID: NCT05006430
What this study is testing
What is Fecal Microbiota Transplantation?
Fecal Microbiota Transplantation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcoholic hepatitis.
Also referred to as (PRIM-DJ2727), FMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health donors. The study aims to enroll 50 patients with SAH who will be randomly assigned in 1:1 where 25 patients will be assigned to receive orally administered lyophilized PRIM-DJ2727 and Standard of Care (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Any gender; male or female; aged 18- 75 years old.
- Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of \>40 g/day (3 drinks) in females...
You likely can't join if
- Non-alcoholic related liver diseases.
- Patients with swallowing dysfunction at risk of aspiration.
- Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in...
- Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
- Patients with any congenital or acquired immunodeficiency (Other than liver disease)
- Uncontrolled infections, sepsis, or GI bleeding.
See the full eligibility criteria
- Any gender; male or female; aged 18- 75 years old.
- Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of \>40 g/day (3 drinks) in females or \>60 g/day (4 drinks) in males for 6 months or more, with less...
- Non-alcoholic related liver diseases.
- Patients with swallowing dysfunction at risk of aspiration.
- Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in the last year.
- Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.
- Patients with any congenital or acquired immunodeficiency (Other than liver disease)
- Uncontrolled infections, sepsis, or GI bleeding.
- Presence of cancer especially patients with skin cancer who is receiving or may receive systemic chemotherapy or immunotherapy during the study period.
- Underlying disease that might be exacerbated by proposed treatments (e.g. HCV, HBV, HIV, TB).
- Serum creatinine \>2.5 mg/dl at presentation.
- Pregnant and breastfeeding patients.
- Active use drug addiction.
- PI thinks their participation would pose a health risk e.g. patients with very severe AH with MELD score \>30 or Maddrey DF \> 60 or patient will be getting liver transplantation imminently.
- Any other major illness/ condition that in the investigators judgment, will substantially increase the risk to the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.