Research coming in from the University of Texas Health Science Center at Houston shows that when it comes to treating those with C. difficile, frozen and freeze-dried products for Fecal Microbiota Transplantation are nearly as effective as fresh product.
Patients with Clostridium difficile infections can suffer severe colonic inflammation, which could lead to symptoms ranging from recurrent diarrhea (which could last from weeks to months) to kidney failure, or even death. C. difficile is the most frequent hospital-acquired infection in the United States, and, according to the Centers for Disease Control and Prevention (CDC), it is responsible for about 29,000 deaths annually. C. difficile is particularly problematic for nursing home populations, patients taking antibiotics, and individuals with compromised immune systems or underlying medical conditions. Due to this, researchers are constantly on the lookout for better ways to treat the infection. Research coming in from the University of Texas Health Science Center at Houston may lead to just that, in the form of a pill.
Currently, doctors treat the bacterial infection with a process called fecal matter transplantation (FMT), which involves extracting healthy bacteria from another individual’s fecal matter and then processing and transferring that bacteria to the infected patient directly. This process usually involves a colonoscopy, endoscopy, sigmoidoscopy, or enema, and usually does not permanently resolve the issue, leading to ongoing FMTs over time. The infection is difficult to eliminate because, although antibiotics can kill off the bacterium, they do not affect bacterial spores; these spores later release toxins that make the patient sick again. Bacterial diversity in the gut, which is reduced or eliminated by antibiotics, is the best shot that these patients have at controlling the spore population after the bacteria are gone.
FMTs can be a “logistical nightmare,” said Herbert L. DuPont, MD, director of the Center for Infectious Diseases at the University of Texas School of Public Health. Dr. Dupont is the lead author on a study indicating that frozen and freeze-dried microbiota are as effective in treating C. difficile infections as “fresh material.” Frozen or freeze-dried microbiota can be administered in pill form at a patient’s or practitioner’s convenience, whereas fresh transfers require a donor and recipient to spend hours at the hospital to obtain the fecal sample, refine it, and then deliver it to the infected patient. “We knew an effective capsule would make treatment more convenient for people,” Dr. Dupont told Contagion®, adding that he is currently in the process of testing the safety and efficacy of pill's delivery method.
Dr. Dupont and his team evaluated 72 patients, all of whom were infected with C. difficile and had experienced at least three bouts of symptoms. The group was “randomized in a double-blind study to receive fresh, frozen, or lyophilized FMT product” from eight different healthy donors, the team reported. Although cure rates for fresh-product FMT were the highest (100%), the effects of the treatments after one month “resembled” each other, reported the scientists. Lyophilized product treatments resulted in a 78% cure rate, and frozen product treatments resulted in an 83% cure rate. The main difference between cure rates was the speed at which the patient was cured; fresh material improved bacterial diversity in the patients’ guts in about a week, compared to 30 days for the lyophilized material.
The biggest benefit of treating C. difficile infections with freeze-dried material is that the process is so much more convenient, Dr. Dupont said. He compared the pill that the team is currently testing to “instant coffee” because it is very stable and can be transported easily.
One of the participants in the study is already sold on the new method of treatment. He gleefully told Science Daily that his cure is “a miracle!” He added that prior to the new treatment, he had been considering retiring because infection had made him so ill and the FMT process was so time consuming. “I love teaching, and I can’t tell you what it was like to be healthy again, to be able to do my job and not retire before I was ready,” he said.