BARCELONA, Spain — A single session of fecal microbiota transplantation (FMT) significantly improved alcohol abstinence and reduced relapse rates for up to 6 months in patients with alcohol-associated cirrhosis and alcohol use disorder, according to results from a randomized controlled trial.
Three–month data found that more than 20% of participants on FMT remained abstinent, suggesting that modifying the gut microbiome may offer a novel way to target the gut-brain axis and reduce alcohol craving in a patient population with few effective therapeutic options.
“Fecal microbiota transplantation works,” said Srajit Singh, MD, DM, hepatologist at the Institute of Liver and Biliary Sciences, New Delhi, India. “For alcohol-associated liver disease, we have to treat the cause, and the cause is alcohol. But addiction is a major problem and there are limited treatment options available,” he told Medscape News Europe.
“These patients come to us saying, ‘Doctor, we have tried everything. I want to live. Please do something,’” said Singh, emphasizing the desperate situation of these patients.
He presented his research as a poster at the European Association for the Study of the Liver (EASL) Congress 2026.
Targeting the Gut-Brain Axis
Few pharmacologic options are available to reduce alcohol craving in people with liver cirrhosis. Singh explained that increasing evidence suggested that chronic alcohol use alters the gut microbiome, reducing beneficial bacterial species while promoting an unhealthy microbial imbalance. Experimental studies have also implicated the gut-brain axis in alcohol craving and addiction behavior, he added.
To explore whether restoring the microbiome could influence alcohol consumption, Singh and colleagues conducted a single-center randomized controlled trial involving 54 men with alcohol-associated liver disease and alcohol use disorder. The primary endpoint was alcohol abstinence at 1 month. Secondary endpoints included abstinence at 3 and 6 months, and craving scores. Gut microbiota changes were also determined using 16S metagenomic analysis.
Participants were randomly assigned 1:1 to receive either standard medical treatment alone — including baclofen, counselling, and psychiatric support — or standard medical treatment plus a single FMT delivered via upper gastrointestinal endoscopy. The transplanted microbiota came from carefully screened healthy blood relatives, most of whom were younger than 35 years, nonsmokers, and nondrinkers. Patients were followed for 6 months.
Significant Improvement in Abstinence
At 3 months, complete alcohol abstinence was achieved in 22% of patients receiving FMT compared with none of those receiving standard treatment alone (P = .023).
Singh reported that the benefit appeared greatest early after treatment, with abstinence rates of 52% in the FMT group and 33% in the control group at 1 month, although the difference was not statistically significant.
Relapse rates (moderate and severe) were also lower among FMT recipients. At 3 months, moderate relapse occurred in 41% of FMT-treated patients compared with 74% of control individuals (P = .027). However, by 6 months, there were moderate relapse rates in 48% and 100%, respectively (P < .001).
Patients receiving FMT also experienced significant reductions in alcohol craving scores (P < .05 for FMT vs standard care). Model for End-Stage Liver Disease scores, a marker of liver disease severity, improved more rapidly and to a greater extent in the FMT group than in the control group.
Microbiome Changes May Explain the Effect
The investigators performed 16S ribosomal RNA sequencing on stool samples collected before and after FMT. Patients who remained abstinent demonstrated enrichment of several potentially beneficial bacterial taxa, including members of the Ruminococcaceae and Bifidobacteriaceae families.
The findings support the hypothesis that restructuring the gut microbiome may influence addictive behaviors through gut-brain signaling pathways.
“Our study aimed to target the gut-liver-brain axis,” Singh said. “We believe the microbiome changes may help reduce the addictive signals between the gut and the brain.”
The study builds on previous work by Jasmohan Bajaj, MD, and colleagues in the US, who reported encouraging results from a small pilot study using FMT in patients with alcohol use disorder.
Effect May Be Temporary
A notable finding was that the apparent benefit of a single FMT session appeared strongest at around 3 months, Singh said. Although some advantages persisted at 6 months, he believed repeat dosing may be needed.
“After that [3 months], there was a trend suggesting it may start to wear off. A second dose at around 3 months may be beneficial,” he said.
He added that future studies incorporating repeat FMT administration and more comprehensive metagenomic analyses are planned.
Promising but Preliminary
Commenting independently, Jose Ursic-Bedoya, MD, hepatologist at Montpellier University Hospital, Montpellier, France, described the results as encouraging, particularly given the lack of effective treatment options available for patients with cirrhosis and alcohol use disorder. “Any reduction in alcohol consumption can be beneficial for these patients,” he said. “If we have something relatively easy to administer that can induce a reduction in drinking, then of course it could be useful.”
He also reflected that the effect appeared to diminish over time. “One of the key points is that the benefit seems to occur over a relatively short period and may not be sustained. The next study may need to evaluate sequential treatment. Perhaps repeated dosing would improve outcomes further.”
Still, he described the findings as “a promising start.”
Singh explained that further work was needed. “We need more randomized controlled trials, longer follow-up, and perhaps multiple doses of FMT. But this approach may help us keep alcohol addiction in check and improve outcomes for patients with cirrhosis.”
Singh and Ursic-Bedoya reported having no relevant financial relationships.
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