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Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: Investigation of the Gut-Brain Axis in Alcohol Use Disorder: A Randomized Clinical Trial on the Role of Fecal Microbiota Transplantation in Abstinence, Inflammation, and Emotional-Behavioral Regulation.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2026-11-16
Completion Date
2029-11
Last Updated
2026-10-29
Healthy Volunteers
Yes
Interventions
Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure
Fecal material will be processed under GMP conditions within 6 hours of donation, homogenized, filtered through 330 μm mesh, aliquoted in 250 mL volumes and stored at -80°C until use; FMT will be performed at week 0 by colonoscopy with release of the material into the proximal colon; All participants, in both study arms, will receive standardized CBT delivered by certified therapists in the field of addiction according to a validated manual
Locations (1)
Fondazione Policlinico Gemelli IRCCS, Roma, RM 00168
Roma, Roma, Italy