Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Официальное название

Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Intestinal Microbiota Transplant (IMT) Capsules
  Capsules containing freeze-dried intestinal microbiota from healthy human donors
• Препарат Placebo Capsules
  Capsules containing an inactive substance ("sugar pill")

Первичные конечные точки

• Number of abstinent days [Срок оценки: 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 [Срок оценки: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)]
• Phosphatidyl Ethanol (PEth) level change [Срок оценки: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)]

Вторичные конечные точки (12)

• Change in markers of alcohol in urine [Срок оценки: Baseline to 3 months after treatment]
• Change in markers of alcohol in blood [Срок оценки: Baseline to 3 months after treatment]
• Change in percentage of heavy drinking days [Срок оценки: Baseline to 3 months after treatment]
• Change in alcohol craving [Срок оценки: Baseline to 3 months after treatment]
• Change in life problems [Срок оценки: Baseline to 3 months after treatment]
• Number of hospitalizations [Срок оценки: 6 months]
• Number of serious adverse events [Срок оценки: 6 months]
• Change in microbial composition [Срок оценки: Baseline to 3 months after treatment]
• Change in liver function [Срок оценки: Baseline to 3 months after treatment]
• Change in Psychometric hepatic encephalopathy score (PHES) [Срок оценки: Baseline to 3 months after treatment]
• Change in EncephalApp Stroop Test [Срок оценки: Baseline to 3 months after treatment]
• Change in health related quality of live (HRQOL) [Срок оценки: Baseline to 3 months after treatment]

Критерии участия

Критерии включения

->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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Hunter Holmes McGuire VA Medical Center — Richmond
• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT05548452 · HM20025442 · R01AA029398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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