FMT Capsules Noninferior to Colonoscopy in Preventing RCDI

A capsule containing frozen donor bacteria was shown to be 96% effective in treating C. diff.

Dina Kao, MD

A Canadian clinical trial has found that a fecal microbiota transplant (FMT) is as effective in treating Clostridium difficile (C. diff) whether delivered by colonoscopy or via capsule.

The findings of the study, led by researchers from Alberta Health Services, could revolutionize and broaden the use of FMT, which restores the healthy balance of bacteria living in a patient with C. diff.

“This will transform the way people think about how we deliver fecal microbiota transplant,” Dina Kao, MD, lead study author, associate professor, University of Alberta’s Faculty of Medicine and Dentistry, gastroenterologist, Alberta Health Services, said in a statement. “Capsules have numerous advantages over colonoscopy. They are non-invasive, they’re less expensive, they don’t have any of the risks associated with sedation and they can be administered in a doctor’s office.”

The oral capsules containing frozen donor bacteria were shown to be 96.2% effective in treating the infection, the same success rate as those receiving transplant by colonoscopy.

The noninferiority randomized clinical trial included 116 adults with recurrent C. diff infection (RCDI) studied between Oct. 2014—Sept. 2016, with a follow-up through Dec. 2016.

Participants were randomly assigned to FMT by capsule or colonoscopy at a 1:1 ratio, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. Stool was provided by 7 healthy donors.

The patients randomized to the capsule group took an average of 40 pills over the course of 30—60 minutes at an outpatient clinic, while those who underwent the colonoscopy endured a hospital procedure that required heavy sedation and a full day to recover.

The primary outcome was the proportion of patients without RCDI 12 weeks after FMT.

Secondary outcomes included serious and minor adverse effects, changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst).

Quality of life scores significantly increased for participants after FMT, with no significant difference between the treatment groups.

The proportion without recurrence throughout 12 weeks was 96.2% after a single treatment in a group treated with oral capsules and in a group treated via colonoscopy, meeting the noninferiority margin of 15%.

Rates of minor adverse effects were 5.4% for the capsule group versus 12.5% for the colonoscopy group. One patient in each group died of unrelated underlying cardiopulmonary illness.

Although 97% of all patients that participated in the study said they would undergo the assigned delivery method again if necessary, a significantly greater proportion (66%) of participants receiving the capsules rated their experience as not at all unpleasant, compared to only 44% of patients who didn’t find the colonoscopy unpleasant. The pills have no scent or taste.

Researchers noted the cost different, and while FMT via a colonoscopy costs $874 per patient, FMT by capsule costs $308 per patient.

The study, “Effect of Oral Capsule- vs. Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection" was published in JAMA.

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