FDA Approves Poop Therapy that May Revolutionize Gut Medicine

Most of us probably remember the first time we heard about fecal matter transplants. It sounds so out there that it seems more like science fiction than medicine. The first successful fecal matter transplant was in 1958. But it wasn’t until much later that it became a widely accepted practice.  

Clostridium difficile, or C. difficile, is a bacterium that causes an infection in the large intestine. It can cause life-threatening diarrhea and is linked to 15,000-30,000 deaths a year in the U.S. Using fecal mater transplants from healthy donors has been a standard procedure to fix the problem for a long time.

While the treatment has existed, it was considered “investigational” by the FDA. It wasn’t standardized. The donor sample could be given via a pill, enema or colonoscopy. Finding and screening a donor could be complicated. And insurance often didn’t cover the treatment as it was considered experimental.

Now, the FDA has approved Rebyota, a treatment that contains gut bacteria from healthy human donors. It’s approved for people over the age of 18 who have been treated repeatedly for C. difficile. The standardized nature makes it more likely that insurance will cover it. It also clearly lists the side effects: abdominal pain, diarrhea, abdominal bloating, gas and nausea. Additionally, there is a possibility that people may have a food allergic reaction to something the donor ate. However, the FDA is uncertain, writing, “The potential for the product to cause adverse reactions due to food allergens is unknown.”

Treatments for C. difficile include strong antibiotics that can harm the gut’s microbiome. Rebyota is administered via an enema and replenishes good gut bacteria through samples of microbes from the feces of healthy donors. The safety and efficacy of the new treatment were tested in randomized, double-blind, placebo-controlled clinical studies.

Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. 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.”

Rebyota is a much-needed new treatment that offers hope to the thousands of people who suffer from recurrent C. difficile infection each year,” said Brent Ragans, President of Ferring Pharmaceuticals U.S., the maker of the treatment. “Rebyota has the potential to impact not only patients and caregivers, but also the healthcare system.”

After replenishing the gut with healthy bacteria, it’s essential to feed it with fiber and other prebiotics. Prebiotics feed the microbiome to keep it functioning well. After taking a strong course of antibiotics, or going through any situation that can harm your gut, probiotics can help heal the damage. Prebiotics help you stay the course to maintain proper health.  

Banner image: Kat Smith via Pexels

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