The US Food and Drug Administration (FDA) announced yesterday that it has approved a fecal microbiota product for the prevention of recurrent Clostridioides difficile infection (CDI) in adults.

Approval of Rebyota, which was developed by Swiss biopharmaceutical company Ferring Pharmaceuticals, was based on analysis of multiple randomized clinical trials. The efficacy analysis found that the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%), while safety analysis found there were no serious treatment-related adverse events. The most common side effects after one dose of Rebyota were abdominal pain, diarrhea, abdominal bloating, gas, and nausea.

CDI—which occurs when C difficile bacteria multiply in the gut and release toxins, typically following antibiotic use—is a leading cause of hospital-acquired diarrhea and causes an estimated 500,000 and 29,000 deaths in the United States each year. Up to 35% of CDI cases recur after the initial episode, and patients who have recurrent infections have a significantly higher risk of further infection.

Prepared from stool donated by qualified individuals and delivered via enema, Rebyota is the first fecal microbiota product to be approved by the FDA. Fecal microbiota transplant therapy has been found in several studies to be an effective treatment for recurrent CDI compared with the standard of antibiotic therapy.

"Recurrent CDI impacts an individual's quality of life and can also potentially be life-threatening," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency press release. "As the first FDA-approved fecal microbiota product, today's action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI."

"We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs," Ferring President Per Falk, MD, PhD, said in a company press release.

Rebyota was approved for use in patients 18 years and older after they have completed antibiotic treatment for recurrent CDI.

COVID-19 infection is associated with increased liver stiffness, a sign of possible long-term liver injury, according to the results of a study presented today at the annual meeting of the Radiological Society of North America.

The study was based on COVID-19 patients and uninfected controls seen at Massachusetts General Hospital between 2019 and 2022. All participants underwent ultrasound shear-wave elastography, which allows clinicians to measure liver tissue. Liver stiffness is associated with both inflammation and fibrosis.

Participants were separated into three groups: 31 people with polymerase chain reaction (PCR)-confirmed COVID-19 infections at least 12 weeks before the ultrasound, 50 people who had the ultrasound before the pandemic, and 50 people who had the ultrasound during the pandemic but had negative COVID tests.

In the COVID-positive group, elastography exams were performed an average of 44 weeks after a positive PCR test result.

The 31 participants with COVID-19 had statically higher median liver stiffness readings than pandemic controls; however, the prepandemic control group also had higher levels of stiffness.

"We don’t yet know if elevated liver stiffness observed after COVID-19 infection will lead to adverse patient outcomes," said Firouzeh Heidari, MD, a study author, in a press release. "We are currently investigating whether the severity of acute COVID-related symptoms is predictive of long-term liver injury severity."

Over half of survey respondents in East England who had COVID-19 in 2020 reported persistent long-COVID symptoms and continued use of health services in early 2021, with a disproportionate burden among overweight women.

The findings were published yesterday in PLOS Global Public Health by a team led by Norwich Medical School researchers at the University of East Anglia. The researchers examined primary care records, and in February of 2021 sent an online survey on lingering symptoms and healthcare use to Norfolk residents infected with the virus by Dec 6, 2020, before COVID-19 vaccines were widely available. The average participant age was 50 years, and 61% were women.

Of 1,487 survey respondents, 52.1% reported long-COVID symptoms. Incidence was 55.9% in women and 46.0% in men. Male sex was protective (relative risk [RR], 0.748), while higher body mass index (BMI) was tied to greater risk (RR, 1.031 per 1 kilogram per meter squared [kg/m²]). "Based on the above, it can be estimated that for a man to have the same probability as female of same age with normal BMI they have to have a BMI over 35 kg/m²," indicating obesity, the researchers wrote.

Age per 1-year increase was not an independent risk factor for lingering symptoms (RR, 1.003).

A total of 25.4% participants used more health services after they recovered from their initial infections, of whom 73.2% reported long-COVID symptoms. Long-COVID patients had significantly higher odds of seeking further health services than those without persistent symptoms (RR, 3.28).

Relative to women, men were much less likely to use further health services (RR, 0.750). Male sex was negatively associated with continued use of health services (RR, 0.618), while BMI was positively linked (RR, 1.027).

In a University of East Anglia news release, senior author Vassilios Vassiliou, MBBS, PhD, said the findings can be used to identify patients at risk for long COVID. "We hope that our work will help policymakers plan local services and also inform the wider public of the scale of the long Covid pandemic," he added.