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New treatment option for Liver Disease; Alcohol-Related
Official title Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
ClinicalTrials.gov ID: NCT05548452
What this study is testing
What is Intestinal Microbiota Transplant (IMT) Capsules?
Intestinal Microbiota Transplant (IMT) Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liver disease; alcohol-related.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.