Fecal transplant pills (artistic rendering) (Marc Bruxelle/Shutterstock)
Posted on 05/09/2023 9:45:48 AM PDT by SeekAndFind
Patients needing a fecal microbiota transplant for recurrent Clostridioides difficile (C. diff) infections now have the option of getting stool in pill form.
Fecal transplant pills (artistic rendering) (Marc Bruxelle/Shutterstock)
The U.S. Food and Drug Administration (FDA) recently approved Vowst, the first oral biologic drug for fecal microbiota that was shown in clinical trials to be as effective as fecal microbiota transplants given rectally. Biologic drugs are derived from blood, proteins, bacteria, and other living organisms.
In a traditional fecal microbiota transplant or FMT, healthy donor stool is transferred into the colon of a patient, usually via colonoscopy or retention enema. Late last year, the FDA approved the first microbiota product for rectal administration to C. diff patients.
C. diff, often contracted by taking antibiotics, is highly a contagious bacterial infection that causes severe diarrhea, abdominal pain, and fever and can result in organ failure and even death. Recurrent infections within two to eight weeks are a problem for about one in six patients, according to the U.S. Centers for Disease Control and Prevention (CDC). Risk factors include recent hospital or nursing home stay, a weakened immune system, and previous C. diff infections.
In response to the approval of the new oral microbiota product, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release:
“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.”
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.
That’s a potential concern, Dr. Sabine Hazan, gastroenterologist, CEO of ProgenaBiome, and expert on gut bacteria told The Epoch Times.
“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.”
The FDA news release noted that the drug was part of an application designated for a rapid review aimed at getting products to market quickly and was granted Priority Review, Breakthrough Therapy, and Orphan designations.
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.
“We are advancing the field by approving this,” she said. “Hopefully it will do well and it’s safe, and it doesn’t cause any complications. Going from the clinical trials to the clinic are two different things.”
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.
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Read an article recently about babies born via C-section often suffer as they don’t get the bacteria for their gut since they didn’t pass through their mother’s vagina.
sounds logical- I think there’s a lot that is unknown or not understood well-
That’s one pill you won’t chew up to take easier. More than once anyway.
“Wash it down with piss.”
https://www.youtube.com/watch?v=iITtVjtr5-Y
“How do you know that you are getting a good quality turd?”
I wonder if there is a Blood Bank type thing for this?
“I have joked with my family that the world’s worst job now are the people who have to open up the mailed-in turds to be screened for colon cancer. What would motivate you to get out of bed each morning?”
Boy, how many times did I tell you to go to college or trade school so you don’t have to take some ****** job!
I would be willing to make a donation after a meal at Taco Bell.
I wonder if they provide clothes pins for the nose each day.
Good answer.
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