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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA029398 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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:
Participation in this study will last up to 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intestinal Microbiota Transplant capsules | Experimental | Capsules will be provided twice during the trial |
|
| Placebo capsules | Placebo Comparator | Capsules will be provided twice during the trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intestinal Microbiota Transplant (IMT) Capsules | Drug | Capsules containing freeze-dried intestinal microbiota from healthy human donors |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of abstinent days | Number of drinks per day will be measured through self report | 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 | Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio) |
| Phosphatidyl Ethanol (PEth) level change | Change to <70 | Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in markers of alcohol in urine | Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) | Baseline to 3 months after treatment |
| Change in markers of alcohol in blood |
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Inclusion Criteria:
->18 years of age
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmohan S Bajaj, MD | Contact | 804 675 5802 | jasmohan.bajaj@vcuhealth.org | |
| Amy Bartels, BSN, RN | Contact | 804-828-3849 | Amy.Bartels1@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jasmohan S Bajaj, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Recruiting | Richmond | Virginia | 23249 | United States | |
Deidentified data via NIAAA DA website
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo Capsules | Drug | Capsules containing an inactive substance ("sugar pill") |
|
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
| 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 | Baseline to 3 months after treatment |
| Change in alcohol craving | The Alcohol Craving Questionnaire is a 12-item instrument | 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. | Baseline to 3 months after treatment |
| Number of hospitalizations | All hospitalizations and liver-related hospitalizations will be tracked | 6 months |
| Number of serious adverse events | All serious adverse events and intervention related adverse events will be tracked | 6 months |
| Change in microbial composition | Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples. | 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. | Baseline to 3 months after treatment |
| Change in Psychometric hepatic encephalopathy score (PHES) | Brain function will be assessed using the PHES | Baseline to 3 months after treatment |
| Change in EncephalApp Stroop Test | Brain function will be assessed using the EncephalApp Stroop Test | Baseline to 3 months after treatment |
| Change in health related quality of live (HRQOL) | HRQOL will be assessed using the Sickness Impact Profile | Baseline to 3 months after treatment |
| Virginia Commonwealth University |
| Recruiting |
| Richmond |
| Virginia |
| 23298 |
| United States |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |