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: 1. Visit VCU medical center up to 8 times for study visits 2. 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 3. Have blood drawn, urine and stool collected at each visit 4. Have testing done to determine the speed of brain function 5. Keep a diary at home 6. Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling. 7. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Capsules containing freeze-dried intestinal microbiota from healthy human donors
Capsules containing an inactive substance ("sugar pill")
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGNumber of abstinent days
Number of drinks per day will be measured through self report
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Reduction in WHO drinking levels by 1 or greater at month 3
WHO grade by self report
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Phosphatidyl Ethanol (PEth) level change
Change to \<70
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change in markers of alcohol in urine
Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)
Time frame: Baseline to 3 months after treatment
Change in markers of alcohol in blood
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
Time frame: 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
Time frame: Baseline to 3 months after treatment
Change in alcohol craving
The Alcohol Craving Questionnaire is a 12-item instrument
Time frame: Baseline to 3 months after treatment
Change in life problems
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Short Index of Problems is a 15-item instrument which measures medical, psychological, social, occupational, and legal problems.
Time frame: Baseline to 3 months after treatment
Number of hospitalizations
All hospitalizations and liver-related hospitalizations will be tracked
Time frame: 6 months
Number of serious adverse events
All serious adverse events and intervention related adverse events will be tracked
Time frame: 6 months
Change in microbial composition
Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.
Time frame: 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.
Time frame: Baseline to 3 months after treatment
Change in Psychometric hepatic encephalopathy score (PHES)
Brain function will be assessed using the PHES
Time frame: Baseline to 3 months after treatment
Change in EncephalApp Stroop Test
Brain function will be assessed using the EncephalApp Stroop Test
Time frame: Baseline to 3 months after treatment
Change in health related quality of live (HRQOL)
HRQOL will be assessed using the Sickness Impact Profile
Time frame: Baseline to 3 months after treatment