Close to half-a-million people a year suffer from Clostridioides difficile, or C. diff, and more than 29,000 of them died from the bacteria, according to the Center for Disease Control. C. diff results from disruption of healthy, normal bacteria in the colon, often from antibiotics, and causes diarrhea, stomach pain, and fever. In the most severe cases, C. diff can damage the colon and be fatal.
Most cases can be treated with antibiotics. But for patients who suffer recurring cases of C. diff, the path to recovery is a bit more complex. New guidelines for this group, introduced in 2011, recommend fecal microbiota transplantation (FMT), or a procedure in which fecal matter is collected from a healthy donor and placed into the gastrointestinal tract of a patient. These transplants can help replenish the bacterial balance in the gut through colonoscopy or capsules.
Most C. diff patients are elderly and had spent time in healthcare settings under the treatment of antibiotics. While the antibiotics wipe out bad bacteria in the patient, good bacteria resilient to C. diff are also destroyed during the process. Results have been favorable in treating recurrent C. diff with FMT, but Butler University Associate Professor of Pharmaceutical Sciences Hala Fadda is part of a team that has improved cure rates with oral FMT products, while significantly reducing the amount of capsules a C. diff patient must take.
Published in Digestive Diseases and Sciences, Fadda and collaborators designed a capsule coating that dissolves in the colon instead of the stomach. This allows for site-specific delivery to the colon and was found to better restore the gut microbial diversity. These new capsules had faster and more successful cure rates compared to standard capsules that dissolve in the stomach in five minutes.
Published in Digestive Diseases and Sciences, Fadda and collaborators designed a capsule coating that dissolves in the colon instead of the stomach. This allows for site-specific delivery to the colon, which has been found to better restore the gut microbial diversity. These new capsules had faster and more successful cure rates compared to standard capsules that dissolve in the stomach in five minutes.
“The coating is essentially a high fiber starch polymer,” says Fadda, who’s gained expertise through researching how patients consume medicine. “The enzymes produced by colonic bacteria start to chomp away and digest that starch, even with C. diff patients’ lowered bacteria diversity. These enzymes, which break up the starch, are abundant in the colon.”
FMT has been adopted by many hospitals, but Fadda says access to the treatment can be improved. Her new capsules are less invasive and more affordable than a colonoscopy, and they can be shipped from specialist centers around the world.
Healthy donors only
Fadda says there is only a 2.5 percent acceptance rate for fecal donors because the criteria is so strict for FMT. Stool banks like OpenBiome in Boston, Massachusetts, don’t accept potential donors who have traveled to places with communicable diseases in the past six months. They also don’t accept donors who have suffered from digestive diseases, metabolic syndromes, and other conditions.
“You can’t have taken antibiotics in the past three months, and body mass index must be less than 30,” Fadda says. “Evidence suggests a correlation between weight and gut microbial communities.”
As of 2018, 43,000 FMT treatments were issued by OpenBiome, Fada says. However, this number is not representative of total FMT treatments, as some hospitals prepare their own FMT products.
How C. diff spreads
The spores that cause C. diff are abundant in hospitals. They can be spread by visitors, or by healthcare professionals. After the resistant spores are transmitted to patients, they can germinate into vegetative bacterial cells in the colons of vulnerable individuals, and the bacteria produces toxins.
Fadda and her team’s breakthrough will help shorten return hospital stays for many patients suffering from recurrent C. diff. The capsule approach provides an alternative to a colonoscopy—an expensive and invasive procedure some patients might want to avoid—and it looks to be a quick and effective treatment to C. diff while restoring microbiome diversity in the gut.
“Fecal microbiota transplant has been adopted by lots of hospitals,” Fada says. “It’s common in the U.S. and Europe, but accessibility is still an issue. That’s why this capsule offers a significant advantage because it makes FMT more accessible.”
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