NCT05548452

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
8mo left

Started Nov 2022

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

September 16, 2022

Last Update Submit

May 5, 2026

Conditions

Liver Disease; Alcohol-RelatedCirrhosisAlcohol Use Disorder

Keywords

Intestinal Microbiota TransplantAlcohol Use DisorderCirrhosisChronic Liver Disease

Outcome Measures

Primary Outcomes (3)

  • 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)

Secondary Outcomes (12)

  • Change in markers of alcohol in urine

    Baseline to 3 months after treatment

  • Change in markers of alcohol in blood

    Baseline to 3 months after treatment

  • Change in percentage of heavy drinking days

    Baseline to 3 months after treatment

  • Change in alcohol craving

    Baseline to 3 months after treatment

  • Change in life problems

    Baseline to 3 months after treatment

  • +7 more secondary outcomes

Study Arms (2)

Intestinal Microbiota Transplant capsules

EXPERIMENTAL

Capsules will be provided twice during the trial

Drug: Intestinal Microbiota Transplant (IMT) Capsules

Placebo capsules

PLACEBO COMPARATOR

Capsules will be provided twice during the trial

Drug: Placebo Capsules

Interventions

Placebo CapsulesDRUG

Capsules containing an inactive substance ("sugar pill")

Placebo capsules
Intestinal Microbiota Transplant (IMT) CapsulesDRUG

Capsules containing freeze-dried intestinal microbiota from healthy human donors

Intestinal Microbiota Transplant capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Liver DiseasesFibrosisAlcoholism

Interventions

Fecal Microbiota TransplantationCapsules

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsDosage FormsPharmaceutical Preparations

Study Officials

  • Jasmohan S Bajaj, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmohan S Bajaj, MD

CONTACT

804 675 5802jasmohan.bajaj@vcuhealth.org

Amy Bartels, BSN, RN

CONTACT

804-828-3849Amy.Bartels1@vcuhealth.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

November 21, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Deidentified data via NIAAA DA website

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(2)