Patients needing a fecal microbiota transplant for recurrent Clostridioides difficile (C. diff) infections now have the option of getting stool in pill form.
“The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”
New Product, New Risks
Vowst—taken as a dose of four capsules for three consecutive days—is not free of risk. The donated human fecal matter is screened for transmissible pathogens before it is manufactured. However, as the news release pointed out, there is a possibility that donor stool used in the pill could be infected with infectious pathogens, as well as food allergens. The potential for adverse reactions caused by Vowst due to such allergens is unknown.“As much as we can solve one problem, we may be developing others,” she cautioned. “We have to be careful and monitor these patients carefully to make sure they don’t develop other problems.”
There’s no FDA-approved screening test for COVID-19 on the donor samples, Hazan said, so it’s incumbent on the companies that collect donor stool and process it for transplants to do their own testing. The virus can be isolated on a forensics level.
Another concern, she said, is that there’s a reliance on the healthy status of donor stool, which isn’t subject to any particular standard. In Hazan’s practice, patients choose their own donors—usually from among close family members if possible. All health conditions of the donors are considered and discussed.
That’s not to say the new pill cannot be successful. Hazan pointed out that the field of using poop to treat infections and diseases is a bit crazy, but the results with C. diff are some of the more impressive results seen.
Trial Results
According to the FDA news release, in a U.S. and Canadian randomized, double-blind, placebo-controlled, clinical study of the safety of Vowst, 89 participants received Vowst and 93 received placebo treatment. CDI recurrence in Vowst-treated participants was 12.4 percent, compared to 39.9 percent in placebo-treated participants. The FDA also reported that Vowst recipients were more likely to report abdominal bloating, fatigue, constipation, chills, and diarrhea after treatment.‘Proof of Concept’
Though it appears it’s the good bacteria that make fecal transplants effective, scientists don’t know for certain why they work so well, according to Dr. Neil Stollman, chairman of gastroenterology at Alta Bates Summit Medical Center. He predicted at the February Malibu Microbiome Meeting that the next FDA-approved fecal microbiota product would be for C. diff infections.“Really C. diff is our proof of concept of [dysbiosis]. We have an illness caused by dysbiosis that we can reliably cure by transplanting healthy stool, and I think that’s absolutely extraordinary,” Stollman said.
“I’m more excited and interested in the fact that this is a tiny little window for a much bigger conversation about bacterial therapy and targeted biome restoration,” he said.
Hazan believes colonoscopy is the better delivery system for a transplant since the home for most of the gut bacteria is the cecum, the widest part of the large intestine.
In a procedure that is as personal as introducing someone’s stool into your body, Hazan said conversations about the donor are a vital part of the process. She said there’s already evidence of obesity, hair growth, food cravings, and mental health being altered with the procedure.
“Let’s be honest, you’d rather have poop from your family than a complete stranger,” Hazan said.