Study Paves Way for Clostridium difficile Treatment in Pill Form

UTHealth researchers develop freeze-dried fecal microbiota product

Frozen and freeze-dried products for fecal microbiota transplantation (FMT) are nearly as effective as fresh product at treating patients with Clostridium difficile infection, according to researchers at the University of Texas Health Science Center at Houston (UTHealth) School of Public Health and the Kelsey Research Foundation. The new study, which indicates that a pill form of treatment could be effective as well as more convenient for patients and physicians, was published in Alimentary Pharmacology & Therapeutics.

C. difficile is a bacterium that causes inflammation of the colon. People infected with the bacteria can have recurrent diarrhea that lasts months or even years. It is the No. 1 hospital-acquired infection in the United States and leads to 29,000 deaths each year, according to the Centers for Disease Control and Prevention. The illness most commonly affects people in hospitals and nursing homes who are taking antibiotics and may have an underlying medical condition.

FMT is a procedure in which a doctor extracts bacteria from fecal matter from a healthy donor, mixes the bacteria in a solution, and transfers the microbiota to a person with C. difficile infection via colonoscopy, endoscopy, sigmoidoscopy, or enema. The new study showed that the fecal microbiota can be frozen or freeze-dried. The procedure replenishes “good” bacteria killed by antibiotics in the microbiome.

For the study, UTHealth and Kelsey Research Foundation investigators enrolled 72 patients who had at least three bouts of recurrent C. difficile infection in a clinical trial and treated them with a fresh, frozen, or freeze-dried FMT product via colonoscopy. Fresh FMT produced a 100% cure rate among participants; frozen product produced an 83% cure rate; and freeze-dried product produced a 69% cure rate.

Frozen and fresh product fully restored the microbiota diversity among participants within seven days after treatment. The researchers saw some improvement in microbiota diversity among participants treated with freeze-dried product after seven days, and full restoration of healthy bacteria within 30 days.

“This is the first study to show that frozen and freeze-dried microbiota is as good as fresh material, so that we never have to use fresh again,” said senior author Herbert L. DuPont, MD. “It’s a logistical nightmare to use fresh product. If we were going to treat you today, a donor would have come in two hours before; we would have already isolated the sample, and then we would have to administer it the same day. A pill form of the product could make all of this easier.”

Physicians typically treat C. difficile infections with antibiotics, which can destroy bacterial toxins. However, C. difficile spores are much harder to kill, and once the antibiotics have eradicated both “good” and “bad” bacteria in the gut, the remaining spores can release additional toxins, the investigators say. There is a 50% chance that a person with a C. difficile infection will develop a recurrent infection because of the toxins.

Source: UTHealth School of Public Health; March 13, 2017.