A Capsule for a Scourge

155612753Who knew that transplanting poop, otherwise known as fecal material, stool, gut microbiota and other less scientifically rigorous terms, could successfully treat at least one modern scourge, Clostridium difficile infection? Now Rick and I talk about frozen, encapsulated fecal microbiota transplant administered orally on this week's PodMed, and as reported in JAMA.  In spite of the substantial yuck factor, turns out the strategy works in the vast majority of patients.  Good news indeed for those with this increasingly common cause of fulminant diarrhea that may result in death.

Researchers with previous experience in fecal transplant to treat C. dif infection, as it is fondly abbreviated in medical circles, mused that while direct transplant either right into the large bowel or administered via a nasogastric tube worked well in the majority of patients, several limitations were apparent.  These included the need to transplant fresh material from a donor related to the patient, who has previously been screened for the organism, and placement of a infusion device to accomplish the transplant. They hit upon the idea that screened, frozen material could be used instead, and had used this in a previous study for infusion via a nasogastric tube.  It was a short leap to aliquoting transplant material into capsules and administering them orally.

The current study enrolled twenty patients ranging in age from 11 to 89 years, to receive the capsules. All of the subjects had had at least three previous episodes of mild to moderate C. dif infection and had failed treatment with the usual antibiotic therapy, or had been hospitalized at least twice with severe C. dif infection. The fact that one of the subjects was only 11 years old points to the disturbing recent increase in infections among the pediatric population. Each subject was given 15 capsules of fecal transplant material on two consecutive days by an investigator. Those who failed to respond were offered an additional course of treatment.

Here are the very impressive results as reported in the paper: No serious adverse events...were observed. Among 20 patients treated, 14 had clinical resolution of diarrhea after the first administration of FMT [fecal microbiota transplant] remained symptom free at 8 weeks. All 6 nonresponders were re-treated at a mean of 7 days after the first procedure. Of these 6, 5 patients had resolution of diarrhea after the second treatment. However, 1 patient relapsed within the predetermined 8-week follow-up after initial diarrhea resolution, resulting in an overall rate of diarrhea resolution of 90%. The only variable significantly associated with response to first treatment was overall health score prior to FMT. Patients who needed a second treatment to achieve resolution of diarrhea had lower pretreatment health scores (were more symptomatic) than patients who had diarrhea resolution after a single administration..  Wow.  That's pretty good.  So what about those capsules?

Fecal donors were healthy, non pregnant adults 18 to 50 years of age, taking no medications and having a normal body mass index.  Clearly no previous history of C. dif infection was necessary and all donors were screened for infectious disease according to blood bank procedures.  Previous to stool donation all donors were requested to avoid allergenic foods but otherwise to eat normally.  Their stool was frozen and stored for 4 weeks to allow rescreening of donors before their microbiota were transplanted.  All in all, sounds like a fairly innocuous procedure to me, and one that may also be readily expanded.  Rick and I agree that such a strategy sounds promising indeed to stem the tide of C.dif infection.

Other topics this week include a really cool use of stem cells to treat macular degeneration and dystrophy in the Lancet, an update on Ebola projections in NEJM, and exercise and depression in teenagers in JAMA Pediatrics.  Until next week, y'all live well.

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