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NCT07902635
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Conditions: Alcohol Use Disorder (AUD), Alcohol Abstinence
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 78
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Fondazione Policlinico Gemelli IRCCS, Roma, RM 00168 Roma Roma
Summary
A non-profit study involving patients with moderate-to-severe Alcohol Use Disorder (AUD), designed to investigate whether correcting intestinal dysbiosis through Fecal Microbiota Transplantation (FMT) from healthy abstinent donors, combined with standard cognitive behavioral therapy (CBT), improves abstinence and modulates inflammation, intestinal permeability, and neurobehavioral outcomes.
The rationale is based on preclinical evidence and clinical signals already observed in alcohol-related liver disease; however, randomized controlled trials in non-cirrhotic patients are lacking.
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years; moderate-severe AUD DSM-5; recent alcohol consumption above threshold; ability to sign informed consent and adhere to protocol visits.
Exclusion Criteria:
Severe medical conditions; gastrointestinal pathologies interfering with permeability/FMT; antibiotics within the previous 4 weeks; immunodeficiency; dependence on substances other than alcohol or nicotine; serious psychiatric pathology being treated; specific pharmacotherapy for AUD; pregnancy/breastfeeding; contraindications to colonoscopy or FMT
Source: ClinicalTrials.gov (NCT07902635). StuddyBuddy aggregates publicly available trial information.