HealthDay News — An oral gel capsule formulation of concentrated fecal microbes was well tolerated and stopped recurrent Clostridium difficile infection, according to researchers at IDWeek 2013.
Among 27 patients with more than three episodes of C. difficile who could not tolerate a jejunal catheter and/or were unable to retain fecal enemas, a single 0.47 mL gel capsule containing fecal microbes resolved all but one recurrent infection with no instances of vomiting, Thomas Louie, MD, from the University of Calgary in Canada, and colleagues reported.
The one C. difficile recurrence that occurred after treatment was associated with chronic reinfection at another location in the body, they added.
Previous studies have shown fecal transplant are safe and effective at quickly resolving symptoms of recurrent C. difficile infection with low rates of adverse events, but this therapy has only been delivered via enemas, jejunal catheters or colonoscopy.
To determine if fecal transplants could be effectively administered using a gel capsule, Louie and colleagues enrolled 32 patients with more than three episodes of recurrent C. difficile infection, who were referred for fecal microbe transplant therapy and had their infection controlled with oral vancomycin.
Fecal microbes were isolated from freshly passed feces from related donors and inserted into gelatin capsules, which were double overcapsulated. Feces were collected from related donors mostly, and both donors and recipients were tested for bloodborne infections, parasites and other invasive disease prior to transplant.
Patients discontinued vancomycin treatment the day before the procedure and received a colonic cleansing the morning of the procedure. They then ingested 24 to 34 freshly assembled capsules on an empty stomach over the course of five to 15 minutes. Follow-up was performed at 1 week, 1 month, 3 months and 6 months after therapy, with additional follow-ups occurring for up to 3 years.
After one treatment with the oral formulation, all recipients had arrested recurrent C. difficile and symptoms completed resolved.
Changes in gut flora were also noted — specifically significant increases in the numbers of Bacteroides, Clostridium coccoides, Clostridium leptum, Prevotella, Bifidobacteria and Desulfovibrio, and decreases in Enterobacteriaceae and Veillonella.
“The pills are a one-shot deal and seem to work. They are easier for patients and are well-tolerated,” Louie said in a statement.