Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
NCT05548452, Phase 1, Phase 2, Active not recruiting, Virginia Commonwealth University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease | ClinicalTrials.gov |
| NCT number | NCT05548452 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Virginia Commonwealth University | ClinicalTrials.gov |
| Conditions | Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder | ClinicalTrials.gov |
| Interventions | Intestinal Microbiota Transplant (IMT) Capsules, Placebo Capsules | ClinicalTrials.gov |
| First posted | 2022-09-21 | ClinicalTrials.gov |
| Last updated | 2026-08-24 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of abstinent days | 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 | ClinicalTrials.gov |
| Primary | Change in WHO drinking levels by 1 or greater at month 3 | Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio) | WHO grade by self report | ClinicalTrials.gov |
| Primary | Phosphatidyl Ethanol (PEth) level change | Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio) | Change to \<70 | ClinicalTrials.gov |
| Secondary | Change in markers of alcohol in urine | Baseline to 3 months after treatment | Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) | ClinicalTrials.gov |
| Secondary | Change in markers of alcohol in blood | Baseline to 3 months after treatment | Blood samples will be analyzed for Phosphatidyl Ethanol (PEth) | ClinicalTrials.gov |
| Secondary | Change in percentage of heavy drinking days | Baseline to 3 months after treatment | Self reported drinking behavior will be used to calculate percentage of heavy drinking days | ClinicalTrials.gov |
| Secondary | Change in alcohol craving | Baseline to 3 months after treatment | The Alcohol Craving Questionnaire is a 12-item instrument | ClinicalTrials.gov |
| Secondary | Change in life problems | Baseline to 3 months after treatment | The Short Index of Problems is a 15-item instrument which measures medical, psychological, social, occupational, and legal problems. | ClinicalTrials.gov |
| Secondary | Number of hospitalizations | 6 months | All hospitalizations and liver-related hospitalizations will be tracked | ClinicalTrials.gov |
| Secondary | Number of serious adverse events | 6 months | All serious adverse events and intervention related adverse events will be tracked | ClinicalTrials.gov |
| Secondary | Change in microbial composition | Baseline to 3 months after treatment | Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples. | ClinicalTrials.gov |
| Secondary | Change in liver function | Baseline to 3 months after treatment | The Model for end-stage liver disease (MELD) score will be used to asses changes in liver function. | ClinicalTrials.gov |
| Secondary | Change in Psychometric hepatic encephalopathy score (PHES) | Baseline to 3 months after treatment | Brain function will be assessed using the PHES | ClinicalTrials.gov |
| Secondary | Change in EncephalApp Stroop Test | Baseline to 3 months after treatment | Brain function will be assessed using the EncephalApp Stroop Test | ClinicalTrials.gov |
| Secondary | Change in health related quality of live (HRQOL) | Baseline to 3 months after treatment | HRQOL will be assessed using the Sickness Impact Profile | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AA029398 | Fecal microbiota transplant for Alcohol-Associated Cirrhosis | BAJAJ, JASMOHAN S; KHORUTS, ALEXANDER | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2022 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)