Fecal Transplant No More Effective Than Standard of Care in Treating C. Difficile Infection, Researchers Find

Study terminated for lack of efficacy

Researchers at the University Health Network (UHN) in Toronto, Canada, have found that when treating patients with recurrent Clostridium difficile infection (RCDI), a single fecal transplantation (FT) delivered by enema is no more effective than the existing standard of care (the administration of oral vancomycin taper). The new findings were published in Clinical Infectious Diseases.

During the last decade, FT has re-emerged as a promising treatment for RCDI, with recent studies suggesting that it is highly effective. In an effort to measure the true effectiveness of FT, the UHN team conducted a phase 2/3, single-center, open-label trial in which participants experiencing an acute episode of RCDI were randomly assigned to receive either 14 days of oral vancomycin therapy followed by a single FT of fresh donor stool via enema, or a six-week taper of oral vancomycin only.

After analyzing the results from the first 30 patients, the researchers terminated the study because they found no significant difference between the treatments. In fact, a futility analysis showed that if the study had been completed, it was highly unlikely that FT would show a benefit compared with oral vancomycin taper. This is the first study of its kind to compare FT with the current standard of care for RCDI.

“These findings are quite interesting and show that we have a lot to learn as to how well fecal transplantation works compared to the standard of care before it becomes a mainstream treatment,” said Dr. Susy Hota, medical director of the infection prevention and control program at the UHN. “More research is needed into the many factors that influence the effectiveness of FT, such as donor and patient selection; FT manufacturing; how it is delivered to the patient; the number of times FT needs to be given; and any other variables that could improve outcomes.”

C. difficile is a bacterium that causes mild-to-severe diarrhea and other intestinal symptoms. One in four patients with C. difficile infection experience repeated episodes of infection that can be challenging to cure.

Most cases of C. difficile infection occur in patients receiving antibiotics. Antibiotics can destroy a person’s normal bacteria in the gut, allowing C. difficile bacteria to multiply and cause damage to the intestines.

FT, also known as a stool transplant, is the process of transplanting fecal bacteria from a healthy individual into a recipient with a disease assumed to be caused by the disruption of the microbiota (the natural bacteria) of the gut. The goal of FT is to restore the gut’s microbiota by introducing healthy bacterial flora through a stool infusion. During the last few years, FT has become increasingly popular for treating RCDI.

The new study results, however, indicate that more research needs to be done to determine whether FT is actually more effective than the standard of care.

“The FT field is still evolving, and given the as-yet undefined long-term effects of manipulating the gut’s microbiota, it should be approached with caution,” Hota said.

Source: UHN; January 4, 2017.