An interventional study of Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure in Alcohol Use Disorder (AUD) and Alcohol Abstinence, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 78 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Age 18-70 years; moderate-severe AUD ; recent alcohol consumption above threshold; ability to sign 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; to colonoscopy or FMT
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental arm: FMT + CBT (Fecal Microbiota Transplantation + Cognitive Behavioral Therapy).
Procedure: Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure
Control arm: CBT only (Cognitive Behavioral Therapy).
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
Cumulative days of abstinence
Cumulative days of abstinence at week 12, measured with TLFB and validated by urinary EtG, GGT, CDT, and MCV.
Time frame: 12 weeks
Absolute abstinence
Absolute abstinence at weeks 12/24/48; percentage of abstinent days; heavy drinking days; time to first lapse and relapse; relapse rate; changes in ACTQ, OCDS, BDI-II, STAI-Y, PSS, PSQI, GSRS; changes in inflammatory panel/intestinal permeability/neurotrophic-HPA (TNF-α, IL-1β, IL-6, IL-8, IL-17, TGF-β, MCP-1, IL-10, LPS, ZO-1, proBDNF, mature BDNF, tPA, PAI-1, tPA complex:PAI-1, cortisol, DHEAS); changes in 16S rRNA microbiota (baseline, weeks 4/12/24/48), targeted metabolomics in the predefined subgroup of the first 35 consecutive participants (baseline, weeks 4/12/24), appetite-regulatory peptides (ghrelin, leptin, NPY, PYY, GLP-1), and neurobehavioral performance (IVE, STAXI-2, EPQ-R, CRI, DERS, SF-12, FAB, Stroop, MoCA); adverse events and serious adverse events
Time frame: weeks 12/24/48
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 36 months is close to that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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