Key TakeawaysThe FDA approved a fecal transplant therapy that can reduce the recurrence ofC. diffinfection in adults.This is the first approval for fecal transplant therapy in the United States.Other products to treat diseases of the microbiome could follow close behind.

Key Takeaways

The FDA approved a fecal transplant therapy that can reduce the recurrence ofC. diffinfection in adults.This is the first approval for fecal transplant therapy in the United States.Other products to treat diseases of the microbiome could follow close behind.

For the first time, federal regulators approved afecal transplanttherapy—a medical procedure that introduces a donor’s stool samples into a patient’s intestine to restore microbial balance.

Antibiotics have long been used to treatC. diffinfections. But they can also disrupt the beneficial microbes in the gut, which are important to protecting the colon and keeping infections in check.

About one in six patients who getC. diffwill be infected with it again within eight weeks, and one in 11 people older than 65 diagnosed with the infection will die within a month, according to the Centers for Disease Control and Prevention.The risk of a recurrent infection increases to 40% after gettingC. difftwice and can be up to 65% after the third bout.

“It’s really exciting,” said Sahil Khanna, MBBS, MS, a gastroenterologist and head of theC. diffand gut microbiome research group at Mayo Clinic. “This will help millions of people who get sick fromC. difficileinfection. And we can also potentially study products like this for other diseases now that we’ve got a pathway for FDA approval.”

Long-Term Problems After C. Diff

Why Antibiotics Aren’t Great for TreatingC. diff

The gastrointestinal tract is an ecosystem teeming with microbes. These are important for digesting certain foods, controlling the immune system, and protecting the intestines from disease-causing bacteria. During aC. diffinfection, the bacteria release toxins that cause damage to the colon and cause watery diarrhea and abdominal cramping.

While antibiotics can kill offC. diff, other beneficial bacteria can suffer collateral damage, throwing off the balance of the microbiome and leaving the gut susceptible to repeatC. diffinfections.

This is partly because antibiotics like vancomycin and Dificid (fidaxomicin) kill part of theC. diffbacteria but don’t always neutralize its spores. FMT, on the other hand, reintroduces microbes that can suppress the proliferation ofC. diffand keep it from overtaking the gut.

This is a vicious cycle—the antibiotics that treat the infection could also increase the chances of new infections.

“No bowel preparation is needed as with a colonoscopy. There is no procedure, there’s no sedation, and there is no recovery time that somebody needs from an anesthesia-based procedure,” Khanna said. “That’s the advantage of this over traditional fecal microbiota transplantation in terms of the process.”

Enema Side Effects

Curry said clinicians often seek fecal transplantation for patients who are not improving on antibiotics, butC. diffisn’t always the culprit for patients with diarrhea. Even if they test positive for the bacteria, a fecal transplant may not work for them.

What to Expect From a Fecal Transplant

“This is not really a therapy to fix your acuteC. diff. This is a therapy to give when your antibiotics forC. diffare nearing their end, and you’re feeling better,” he said. “The problem is now that it’s got an FDA label, people can kind of use it how they best see fit. And I think that’s where it’s going to be very important to educate physicians.”

Accounting for Safety

“There are a lot of checks and balances that are in place to make sure that there’s minimal to no infection transmission,” Khanna said.

Why You Shouldn’t Try a DIY Fecal Transplant

Curry said it will be important to collect more safety data on how this product holds up in young people and in those who are immunocompromised, such as cancer patients who are at high risk for recurrentC. diffinfections. The treatment doesn’t appear to be safe and effective for people who have a low white blood cell count or are taking any antibiotics.

How to Prevent C. Diff Infection From Recurring

“We’ve been stuck in this wilderness where patients don’t have access to a therapy that we know works really well. But there’s been a big question mark hanging over [FMT]: Is this safe?” Curry said. “It’s a human product. Human beings can have infectious diseases, and if you’re not careful, you’ll make a bad situation even worse.”

As more microbiota-based therapies come to market, Curry said it will be important to educate providers about how to use them safely.

“This a desperate infection. People are desperately ill, and they need this therapy, so some of these risks are probably worth taking,” Curry said.

There is an ongoing phase 3 clinical trial to study the long-term efficacy and safety of the therapy in an expanded population with fewer enrollment restrictions.

What This Means For You

4 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.What isC. diff?.Song JH, Kim YS.RecurrentClostridium difficileinfection: risk factors, treatment, and prevention.Gut Liver. 2019;13(1):16-24. doi:10.5009/gnl18071Zhu D, Sorg JA, Sun X.Clostridioides difficilebiology: sporulation, germination, and corresponding therapies forC. difficileinfection.Front Cell Infect Microbiol. 2018;8:29. doi:10.3389/fcimb.2018.00029Khanna S, Assi M, Lee C, et al.Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrentClostridioides difficileinfection.Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x

4 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.What isC. diff?.Song JH, Kim YS.RecurrentClostridium difficileinfection: risk factors, treatment, and prevention.Gut Liver. 2019;13(1):16-24. doi:10.5009/gnl18071Zhu D, Sorg JA, Sun X.Clostridioides difficilebiology: sporulation, germination, and corresponding therapies forC. difficileinfection.Front Cell Infect Microbiol. 2018;8:29. doi:10.3389/fcimb.2018.00029Khanna S, Assi M, Lee C, et al.Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrentClostridioides difficileinfection.Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Centers for Disease Control and Prevention.What isC. diff?.Song JH, Kim YS.RecurrentClostridium difficileinfection: risk factors, treatment, and prevention.Gut Liver. 2019;13(1):16-24. doi:10.5009/gnl18071Zhu D, Sorg JA, Sun X.Clostridioides difficilebiology: sporulation, germination, and corresponding therapies forC. difficileinfection.Front Cell Infect Microbiol. 2018;8:29. doi:10.3389/fcimb.2018.00029Khanna S, Assi M, Lee C, et al.Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrentClostridioides difficileinfection.Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x

Centers for Disease Control and Prevention.What isC. diff?.

Song JH, Kim YS.RecurrentClostridium difficileinfection: risk factors, treatment, and prevention.Gut Liver. 2019;13(1):16-24. doi:10.5009/gnl18071

Zhu D, Sorg JA, Sun X.Clostridioides difficilebiology: sporulation, germination, and corresponding therapies forC. difficileinfection.Front Cell Infect Microbiol. 2018;8:29. doi:10.3389/fcimb.2018.00029

Khanna S, Assi M, Lee C, et al.Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrentClostridioides difficileinfection.Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x

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