Liver Disease; Alcohol-RelatedPhase 1/2IMPACTNCT05548452
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
A Phase 1/2 study testing Intestinal Microbiota Transplant (IMT) Capsules in people with Liver Disease; Alcohol-Related and Cirrhosis, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder
- What is being tested?
- Intestinal Microbiota Transplant (IMT) Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2022to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ->18 years of age
- Advanced liver disease
- Able to give written, informed consent
- Alcohol as a cause of advanced liver disease
- Continued sustained drinking
- Having previously declined a referral to traditional AUD therapy services or having failed such treatments
Who cannot join
- Lack of sustained drinking
- Recent or current alcoholic hepatitis
- Alcohol withdrawal symptoms
- Clinically significant use of illicit drugs
- Uncontrolled mood disorders or primary psychotic conditions
- MELD score>17
Show all 24Show fewer
- Unclear diagnosis of chronic liver disease
- Current hepatic encephalopathy on lactulose and/or rifaximin
- WBC count<1000
- Non-elective hospitalization within last month
- on dialysis
- known untreated, in-situ luminal GI cancers
- chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)
- Dysphagia within 2 weeks
- History of aspiration, gastroparesis, intestinal obstruction
- Ongoing absorbable antibiotic use
- Severe anaphylactic food allergy
- allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
- Adverse event attributable to prior IMT
- ASA Class IV or V
- Pregnant or nursing patients
- acute illness or fever on the day of planned FMT
- Immunosuppression
- Other conditions which make patients are poor candidate for this study per investigator judgement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.
Read the detailed description
These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill").
Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups.
In this study, participants will be asked to do the following things:
- Visit VCU medical center up to 8 times for study visits
- Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month
- Have blood drawn, urine and stool collected at each visit
- Have testing done to determine the speed of brain function
- Keep a diary at home
- Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling.
- Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records.
Participation in this study will last up to 7 months.
- Being tested
- Intestinal Microbiota Transplant (IMT) Capsules, Placebo Capsules
- Keywords
- Intestinal Microbiota Transplant, Alcohol Use Disorder, Cirrhosis, Chronic Liver Disease
- Medical subject headings
- Liver Diseases, Fibrosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal Microbiota Transplant (IMT) CapsulesDrug
Capsules containing freeze-dried intestinal microbiota from healthy human donors
Placebo CapsulesDrug
Capsules containing an inactive substance ("sugar pill")
| Study group | Role | What they receive |
|---|---|---|
| Intestinal Microbiota Transplant capsules | Experimental | Capsules will be provided twice during the trial Receives: Drug: Intestinal Microbiota Transplant (IMT) Capsules |
| Placebo capsules | Placebo comparator | Capsules will be provided twice during the trial Receives: Drug: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of abstinent days
Number of drinks per day will be measured through self report
Measured: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change in WHO drinking levels by 1 or greater at month 3
WHO grade by self report
Measured: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Phosphatidyl Ethanol (PEth) level change
Change to <70
Measured: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Secondary outcomes (12)
Change in markers of alcohol in urine
Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)
Measured: Baseline to 3 months after treatment
Change in markers of alcohol in blood
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
Measured: Baseline to 3 months after treatment
Change in percentage of heavy drinking days
Self reported drinking behavior will be used to calculate percentage of heavy drinking days
Measured: Baseline to 3 months after treatment
Change in alcohol craving
The Alcohol Craving Questionnaire is a 12-item instrument
Measured: Baseline to 3 months after treatment
Change in life problems
The Short Index of Problems is a 15-item instrument which measures medical, psychological, social, occupational, and legal problems.
Measured: Baseline to 3 months after treatment
Number of hospitalizations
All hospitalizations and liver-related hospitalizations will be tracked
Measured: 6 months
Number of serious adverse events
All serious adverse events and intervention related adverse events will be tracked
Measured: 6 months
Change in microbial composition
Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.
Measured: Baseline to 3 months after treatment
Change in liver function
The Model for end-stage liver disease (MELD) score will be used to asses changes in liver function.
Measured: Baseline to 3 months after treatment
Change in Psychometric hepatic encephalopathy score (PHES)
Brain function will be assessed using the PHES
Measured: Baseline to 3 months after treatment
Change in EncephalApp Stroop Test
Brain function will be assessed using the EncephalApp Stroop Test
Measured: Baseline to 3 months after treatment
Change in health related quality of live (HRQOL)
HRQOL will be assessed using the Sickness Impact Profile
Measured: Baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start21 Nov 2022
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease; Alcohol-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548452
- Sponsor's protocol ID
- HM20025442
- Other IDs
- R01AA029398
- Acronym
- IMPACT
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data via NIAAA DA website
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05548452
- Acronym / sponsor ID
- IMPACT / HM20025442
- Keywords
- Intestinal Microbiota Transplant, Alcohol Use Disorder, Cirrhosis, Chronic Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.
Detailed description
These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill").
Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups.
In this study, participants will be asked to do the following things:
- Visit VCU medical center up to 8 times for study visits
- Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month
- Have blood drawn, urine and stool collected at each visit
- Have testing done to determine the speed of brain function
- Keep a diary at home
- Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling.
- Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records.
Participation in this study will last up to 7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal Microbiota Transplant capsules | Experimental | Drug: Intestinal Microbiota Transplant (IMT) CapsulesCapsules will be provided twice during the trial |
| Placebo capsules | Placebo comparator | Drug: Placebo CapsulesCapsules will be provided twice during the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ->18 years of age
- Advanced liver disease
- Able to give written, informed consent
- Alcohol as a cause of advanced liver disease
- Continued sustained drinking
Key exclusion criteria (24 listed)
- Lack of sustained drinking
- Recent or current alcoholic hepatitis
- Alcohol withdrawal symptoms
- Clinically significant use of illicit drugs
- Uncontrolled mood disorders or primary psychotic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal Microbiota Transplant (IMT) CapsulesCapsules containing freeze-dried intestinal microbiota from healthy human donors | Drug | Intestinal Microbiota Transplant capsules |
| Placebo CapsulesCapsules containing an inactive substance ("sugar pill") | Drug | Placebo capsules |
Primary outcome
Number of abstinent days
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Number of drinks per day will be measured through self report
Change in WHO drinking levels by 1 or greater at month 3
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
WHO grade by self report
Phosphatidyl Ethanol (PEth) level change
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change to <70
12 secondary outcomes
Change in markers of alcohol in urine
Time frame: Baseline to 3 months after treatment
Change in markers of alcohol in blood
Time frame: Baseline to 3 months after treatment
Change in percentage of heavy drinking days
Time frame: Baseline to 3 months after treatment
Change in alcohol craving
Time frame: Baseline to 3 months after treatment
Change in life problems
Time frame: Baseline to 3 months after treatment
Number of hospitalizations
Time frame: 6 months
Number of serious adverse events
Time frame: 6 months
Change in microbial composition
Time frame: Baseline to 3 months after treatment
Change in liver function
Time frame: Baseline to 3 months after treatment
Change in Psychometric hepatic encephalopathy score (PHES)
Time frame: Baseline to 3 months after treatment
Change in EncephalApp Stroop Test
Time frame: Baseline to 3 months after treatment
Change in health related quality of live (HRQOL)
Time frame: Baseline to 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified data via NIAAA DA website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmohan S Bajaj, MD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intestinal Microbiota Transplant (IMT) Capsules in people with Liver Disease; Alcohol-Related and Cirrhosis, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of abstinent days (time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.