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Microbiota Transplant

Bacteria Capsules for Alcoholic Liver Disease (IMPACT Trial)

Phase 1 & 2
Recruiting
Led By Jasmohan S Bajaj, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

IMPACT Trial Summary

This trial will test if bacteria capsules can help people with alcohol cravings and drinking.

Who is the study for?
This trial is for adults over 18 with advanced liver disease due to alcohol use, who continue to drink despite previous attempts at treatment. They must be able to consent and not have withdrawal symptoms, significant drug use, uncontrolled mood disorders, certain allergies, a high MELD score (>17), or other severe health issues.Check my eligibility
What is being tested?
The study tests if capsules containing bacteria from healthy donors can reduce alcohol craving and consumption in patients with alcoholic liver disease. Participants will either receive the actual microbiota capsules or placebo capsules without active ingredients.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include gastrointestinal discomfort or allergic reactions to capsule ingredients. The safety and tolerability of these microbiota capsules are key aspects being evaluated.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ethanol
Secondary outcome measures
Change in EncephalApp Stroop Test
Hepatic Encephalopathy
Change in alcohol craving
+9 more

IMPACT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intestinal Microbiota Transplant capsulesExperimental Treatment1 Intervention
Capsules will be provided twice during the trial
Group II: Placebo capsulesPlacebo Group1 Intervention
Capsules will be provided twice during the trial

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
700 Previous Clinical Trials
22,886,965 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
806 Previous Clinical Trials
1,157,975 Total Patients Enrolled
Jasmohan S Bajaj, MDPrincipal InvestigatorVirginia Commonwealth University
7 Previous Clinical Trials
583 Total Patients Enrolled

Media Library

Intestinal Microbiota Transplant (IMT) Capsules (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT05548452 — Phase 1 & 2
Alcoholic Liver Disease Research Study Groups: Intestinal Microbiota Transplant capsules, Placebo capsules
Alcoholic Liver Disease Clinical Trial 2023: Intestinal Microbiota Transplant (IMT) Capsules Highlights & Side Effects. Trial Name: NCT05548452 — Phase 1 & 2
Intestinal Microbiota Transplant (IMT) Capsules (Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548452 — Phase 1 & 2

Frequently Asked Questions

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

How many people can join this research project?

"The information available on clinicaltrials.gov suggests that this trial is actively recruiting patients. The study was first posted on December 1st, 2020 and was most recently edited on November 14th, 2020. They are hoping to recruit 80 participants from 2 different sites."

Answered by AI

Are people still being allowed to sign up for this experiment?

"Yes, this is an active recruitment according to the information provided on clinicaltrials.gov. The trial was first posted on December 1st, 2020 and was last edited on November 14th, 2020. They are looking for a total of 80 patients that will be spread out between 2 sites."

Answered by AI

Who else is applying?

What site did they apply to?
Virginia Commonwealth University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
2022. "Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548452.
All > Liver Disease
~49 spots leftby Nov 2026
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