Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease (IMPACT)
Primary Purpose
Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intestinal Microbiota Transplant (IMT) Capsules
Placebo Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Liver Disease; Alcohol-Related focused on measuring Intestinal Microbiota Transplant, Alcohol Use Disorder, Cirrhosis, Chronic Liver Disease
Eligibility Criteria
Inclusion Criteria:
->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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Hunter Holmes McGuire VA Medical CenterRecruiting
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intestinal Microbiota Transplant capsules
Placebo capsules
Arm Description
Capsules will be provided twice during the trial
Capsules will be provided twice during the trial
Outcomes
Primary Outcome Measures
Change in Alcohol consumption
Number of drinks per day will be measured through self report
Secondary Outcome Measures
Change in markers of alcohol in urine
Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)
Change in markers of alcohol in blood
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
Change in percentage of heavy drinking days
Self reported drinking behavior will be used to calculate percentage of heavy drinking days
Change in alcohol craving
The Alcohol Craving Questionnaire is a 12-item instrument
Change in life problems
The Short Index of Problems is a 15-item instrument which measures medical, psychological, social, occupational, and legal problems.
Number of hospitalizations
All hospitalizations and liver-related hospitalizations will be tracked
Number of serious adverse events
All serious adverse events and intervention related adverse events will be tracked
Change in microbial composition
Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.
Change in liver function
The Model for end-stage liver disease (MELD) score will be used to asses changes in liver function.
Change in Psychometric hepatic encephalopathy score (PHES)
Brain function will be assessed using the PHES
Change in EncephalApp Stroop Test
Brain function will be assessed using the EncephalApp Stroop Test
Change in health related quality of live (HRQOL)
HRQOL will be assessed using the Sickness Impact Profile
Full Information
NCT ID
NCT05548452
First Posted
September 16, 2022
Last Updated
December 13, 2022
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05548452
Brief Title
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
Acronym
IMPACT
Official Title
Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder
Keywords
Intestinal Microbiota Transplant, Alcohol Use Disorder, Cirrhosis, Chronic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intestinal Microbiota Transplant capsules
Arm Type
Experimental
Arm Description
Capsules will be provided twice during the trial
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
Capsules will be provided twice during the trial
Intervention Type
Drug
Intervention Name(s)
Intestinal Microbiota Transplant (IMT) Capsules
Intervention Description
Capsules containing freeze-dried intestinal microbiota from healthy human donors
Intervention Type
Drug
Intervention Name(s)
Placebo Capsules
Intervention Description
Capsules containing an inactive substance ("sugar pill")
Primary Outcome Measure Information:
Title
Change in Alcohol consumption
Description
Number of drinks per day will be measured through self report
Time Frame
Baseline to 3 months after treatment
Secondary Outcome Measure Information:
Title
Change in markers of alcohol in urine
Description
Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)
Time Frame
Baseline to 3 months after treatment
Title
Change in markers of alcohol in blood
Description
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
Time Frame
Baseline to 3 months after treatment
Title
Change in percentage of heavy drinking days
Description
Self reported drinking behavior will be used to calculate percentage of heavy drinking days
Time Frame
Baseline to 3 months after treatment
Title
Change in alcohol craving
Description
The Alcohol Craving Questionnaire is a 12-item instrument
Time Frame
Baseline to 3 months after treatment
Title
Change in life problems
Description
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
Title
Number of hospitalizations
Description
All hospitalizations and liver-related hospitalizations will be tracked
Time Frame
6 months
Title
Number of serious adverse events
Description
All serious adverse events and intervention related adverse events will be tracked
Time Frame
6 months
Title
Change in microbial composition
Description
Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.
Time Frame
Baseline to 3 months after treatment
Title
Change in liver function
Description
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
Title
Change in Psychometric hepatic encephalopathy score (PHES)
Description
Brain function will be assessed using the PHES
Time Frame
Baseline to 3 months after treatment
Title
Change in EncephalApp Stroop Test
Description
Brain function will be assessed using the EncephalApp Stroop Test
Time Frame
Baseline to 3 months after treatment
Title
Change in health related quality of live (HRQOL)
Description
HRQOL will be assessed using the Sickness Impact Profile
Time Frame
Baseline to 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
->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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmohan S Bajaj, MD
Phone
804 675 5802
Email
jasmohan.bajaj@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Bartels, BSN, RN
Phone
804-828-3849
Email
Amy.Bartels1@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data via NIAAA DA website
Learn more about this trial
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
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