This Pill Could Save Your Life – But Would You Still Take it After Knowing What is in it?

Thursday, November 6, 2014

David Grunkemeier, MD

You might need more than a spoonful of sugar to help this medicine go down. Taken for just two days, these pills contain human feces that have been diluted, strained, and frozen into capsules, and may provide a new treatment option for those suffering from relapsing Clostridium difficile infection.

This study that was published in the October 2014 Journal of American Medical Association, by Dr. Youngster et. al., represents the latest and perhaps most exciting installment in Fecal Microbiota Transplant (FMT) for recurrent or relapsing C. difficile infection. FMT is a procedure where fecal matter is collected from a donor, processed and placed inside a patient by mouth or rectum. The purpose of this is to replace the good, healthy bacteria into the intestine to overwhelm and eliminate the troublesome C. difficile.

Having too much bad bacteria, specifically the bad C. difficile, can cause debilitating diarrhea and intestinal inflammation, sometimes requiring hospitalization. Risk factors for getting this infection can include recent antibiotic use, inflammatory bowel disease, and coming into contact with someone who is a carrier of the bad C. difficile.  Once you have it, if you fail at least 2 treatment courses of antibiotics, the infection is considered recurrent or relapsing. The incidence, prevalence, and severity of this bacterial infection has been increasing in the past 7-10 years nationwide, and affects all age groups in healthy and infirmed patients.

Currently, the most cost-effective way to treat this select group of relapsing C. difficile infected patients is FMT via colonoscopy. Treatment success with colonoscopy is 90% or greater. Other modalities, including nasogastric tube and enema administrations are less effective.

What is new in this small case study by Dr. Youngster is the mode of delivery. The treatment consists of 15 pills of frozen, anonymous donor stool, taken each day for 2 days. This two-day regimen was repeated if the first round failed. Clinical resolution of diarrhea was successful in 90% of patients, a rate that is similar to colonoscopy administered FMT. However, time to symptom resolution was significantly longer in Dr. Youngster’s study, than reported by FMT via colonoscopy studies.

If cost can be controlled and it gains FDA approval, this new pill formulation for FMT may represent a significant improvement over current options. Limitations of this current study by Dr. Youngster include small study size and lack of placebo group. Additionally, we do not yet know of the long term side effects, if any, of Fecal Microbiota Transplant.