Low-, high-dose FMT capsules effective for recurrent C. difficile infection

Resolution of diarrhea was achieved in the majority of patients with recurrent Clostridium difficile infection who received either a low- or a high-dose fecal microbiota transplantation capsule, according to data presented at UEG Week 2015.

Jessica R. Allegretti, MD, MPH, from the Crohn’s and Colitis Center at Brigham and Women's Hospital, and colleagues performed a cluster randomized, dose-finding study to evaluate the safety and diarrhea resolution rates of low- and high-dose FMT capsules in patients with three or more recurrent C. difficile infections (CDI). The FMT capsules were made using universal donors from a stool bank.

Jessica R. Allegretti

“This is a less invasive delivery option that will reduce procedure related costs and risks for recurrent CDI,” Allegretti told Healio Gastroenterology. “Availability of these capsules will help expand access to care and potentially allow earlier intervention for patients in need.”

Ten patients from one academic hospital were randomly assigned to receive low-dose FMT (one dose of 30 pills), and seven patients from another academic hospital were randomly assigned to receive high-dose FMT (30 pills daily for 2 consecutive days). Nonresponders were then treated with high dose FMT capsules. The primary endpoints were safety and clinical resolution of diarrhea with no recurrent CDI episodes at 8 weeks.

“The fecal capsules used in this study were well tolerated by patients and both low- and high-dose groups yielded similar efficacy rates as other reported formulations after a single dose,” Allegretti said.

No FMT-related adverse events or serious adverse events occurred, and 71% of high-dose patients vs. 70% of low-dose patients achieved resolution of diarrhea at 8 weeks. Clinical remission was achieved at 72 hours in 100% of the high-dose group vs. 80% of the low-dose group. Five nonresponders were treated with high-dose FMT, four of which had subsequent resolution of diarrhea. The overall response rate was 94%, and the single nonresponder to high-dose FMT capsule extension achieved clinical cure with FMT via colonoscopy.

“Dose finding is important to set evidence-based standards as the optimal dose of fecal capsules is still not known. Ongoing work will evaluate whether even lower doses are possible to reduce the pill burden,” Allegretti said. “Beyond CDI, now we can finally deliver long-term maintenance therapy with fecal capsule to treat chronic diseases. We are now able to perform well designed clinical trials that would be not be possible without the availability of these scalable capsules.” – by Adam Leitenberger

Reference:

Allegretti J, et al. Abstract OP054-LB7. Presented at: UEG Week; Oct. 24-27, 2015; Barcelona, Spain.

Disclosures: Allegretti reports no relevant financial disclosures.