A first-of-its-kind Phase 1 clinical trial, from researchers at Virginia Commonwealth University, has found fecal transplants may be helpful in reducing drinking behaviors in those suffering severe alcohol use disorder (AUD). The results are preliminary, and certainly require further validation, but the study points to a compelling relationship between the gut microbiome and addiction disorders.
The idea fecal microbial transplants (FMT) can improve human health is not new. Modern medicine has been experimenting with the treatment for well over half a century, and Chinese medical practitioners have used the technique for millennia. Over the last decade, however, interest in fecal transplantation has surged, alongside frequent breakthroughs in gut microbiome research.
This new research focuses on the relationship between addiction and the gut microbiome. More specifically, the investigators set out to explore whether a FMT can positively influence drinking behavior in subjects suffering from alcoholism.
“People with alcohol use disorder are often discriminated against and given up on,” says Jasmohan Bajaj, lead author on the new study. “But it’s a disease like any other. There’s a genetic predisposition, and addictions may be promoted by those gut microbes.”
Prior animal studies have indicated FMT can improve negative alcohol-induced behaviors, but this new research is the first robust, placebo-controlled trial in humans. The trial recruited 20 subjects with clinically diagnosed alcohol-use disorder. The cohort was all male, in their mid-60s, and suffering alcohol-related cirrhosis of the liver.
The cohort randomly received either a placebo or active FMT gathered from a single donor high in Lachnospiraceae and Ruminococcaceae, two types of gut bacteria seen in low levels in AUD patients. After one FMT, administered via enema, a variety of physiological and behavioral factors were measured at two follow-up points – 15 days and six months.
“Nine of 10 patients that received the transplant actually had reduction in their cravings and a reduction in the urine measurement of alcohol-related metabolites,” sys Bajaj, referring to the first 15-day follow-up. “They reduced their drinking, objectively.”
This compared to only three of the 10 placebo subjects displaying similar levels of improvement.
Needless to say, this is a small preliminary study, so the researchers are clear in cautioning any broader conclusions regarding the efficacy of FMT for alcoholism are limited. This Phase 1 trial essentially serves as a proof-of-concept, primarily establishing the treatment as safe.
“We conclude in this Phase 1 trial that FMT in men with cirrhosis is safe, associated with reduction in short-term craving and consumption with beneficial microbial change,” the researchers write in the conclusion to the new study. “The FMT-assigned group also demonstrated lower AUD-related events over the follow-up, which need to be confirmed and extended in larger number of patients with AUD.”
The study was published in the journal Hepatology.
Source: Virginia Commonwealth University