Alcohol Use Disorder (AUD)FMT-ACTNCT07902635
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
A study testing Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure in people with Alcohol Use Disorder (AUD) and Alcohol Abstinence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcohol Abstinence
- What is being tested?
- Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years; moderate-severe AUD DSM-5; recent alcohol consumption above threshold; ability to sign informed consent and adhere to protocol visits.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Gemelli IRCCS, Roma, RM 00168
Roma, Roma, 00168
About this study
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.
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.
- Conditions
- Alcohol Use Disorder (AUD), Alcohol Abstinence
- Being tested
- Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure
- Medical subject headings
- Alcoholism, Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) ProcedureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental arm: FMT + CBT (Fecal Microbiota Transplantation + Cognitive Behavioral Therapy). Receives: Procedure: Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure |
| Control Group | No intervention | Control arm: CBT only (Cognitive Behavioral Therapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative days of abstinence
Cumulative days of abstinence at week 12, measured with TLFB and validated by urinary EtG, GGT, CDT, and MCV.
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: weeks 12/24/48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter interventional clinical trial without drug/device: randomized, controlled, open-label, parallel-group, blinded outcome assessment (PROBE) trial. Experimental arm: FMT + CBT. Control arm: CBT alone.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Addolorato Giovanni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giovanni Addolorato, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902635
- Sponsor's protocol ID
- 27491
- Acronym
- FMT-ACT
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07902635
- Acronym / sponsor ID
- FMT-ACT / 27491
- Conditions
- Alcohol Use Disorder (AUD), Alcohol Abstinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter interventional clinical trial without drug/device: randomized, controlled, open-label, parallel-group, blinded outcome assessment (PROBE) trial. Experimental arm: FMT + CBT. Control arm: CBT alone.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) ProcedureExperimental arm: FMT + CBT (Fecal Microbiota Transplantation + Cognitive Behavioral Therapy). |
| Control Group | No intervention | –Control arm: CBT only (Cognitive Behavioral Therapy). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-70 years; moderate-severe AUD DSM-5; recent alcohol consumption above threshold; ability to sign informed consent and adhere to protocol visits.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) ProcedureFecal 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 | Procedure or surgery | Experimental Group |
Primary outcome
Cumulative days of abstinence
Time frame: 12 weeks
Cumulative days of abstinence at week 12, measured with TLFB and validated by urinary EtG, GGT, CDT, and MCV.
1 secondary outcome
Absolute abstinence
Time frame: weeks 12/24/48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Addolorato principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation (FMT) Procedure and Cognitive Behavioral Therapy (CBT) Procedure in people with Alcohol Use Disorder (AUD) and Alcohol Abstinence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Dionisi, MD, MS, PhD (+39 3294773867, tommaso.dionisi1@guest.policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative days of abstinence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.