Antibiotics Weren’t Used to Cure These Patients. Fecal Bacteria Were.

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Since fecal transplants came up at IiME13 this week, this seemed topical.

In a small study, doctors used so-called fecal transplants to treat a serious gut infection in patients. The transplants, from healthy donors, were as effective as antibiotics.

C. difficile kills 14,000 people annually in the United States. A new study finds that transplanting healthy bacteria into a person's intestines is just as effective antibiotic treatment.CreditLouise Murray/Science Source
The bacteria can take over a person’s intestines and be difficult to eradicate. The infection causes fever, vomiting, cramps and diarrhea so severe that it kills 14,000 people a year in the United States alone.

The first line of treatment for the attacking microbes, called Clostridium difficile, is antibiotics. But a group of Norwegian researchers asked if something more unusual — an enema containing a stew of bacteria from feces of healthy people — might work just as well.

The answer, according to a report today in the New England Journal of Medicine, is yes.

The article, https://mobile.nytimes.com/2018/06/02/health/fecal-transplants-bacteria-antibiotics.html

Clostridium difficile infection is a major health problem.1Antibiotic treatment is associated with a considerable rate of recurrence of infection and is related to the emergence of antibiotic-resistant bacteria. Recently, fecal microbiota transplantation has been shown to be effective in the treatment of recurrent C. difficileinfection.2 We undertook a proof-of-concept trial (ClinicalTrials.gov number, NCT02301000) to evaluate the use of fecal microbiota transplantation as treatment for primary C. difficile infection.

The trial began on November 25, 2014, and the first patient underwent randomization on February 22, 2015. From February 2015 through November 2017, at six hospitals in Norway, we randomly assigned 21 adult patients with acute C. difficile infection (≥3 loose stools per day and a positive C. difficile stool test) who had not had previous C. difficile infection to recommended treatment in Norway3 (oral metronidazole at a dose of 400 mg three times a day for 10 days) or fecal microbiota transplantation (one 60-ml enema of anaerobically cultivated human intestinal microbiota) (see the Supplementary Appendix, available with the full text of this letter at NEJM.org).4,5 Achim Biotherapeutics, which provided the fecal microbiota suspension free of charge to the investigators for the purpose of the trial, had no role in the design, conduct, or analyses of the trial. The protocol, available at NEJM.org, was approved by the institutional review board, and all patients provided written informed consent.

The primary end point was clinical cure (firm stool consistency or ≤3 bowel movements per day) with no evidence of recurrence of C. difficile infection when the patient was evaluated at day 70 by an assessor who was unaware of the treatment assignment. Secondary end points were evaluations 4 and 35 days after the initiation of treatment and adverse events. Patients in whom clinical cure was achieved after initial treatment and who had no recurrence of infection were defined as having a full primary response. Patients who received additional treatment to achieve clinical cure, but who did not have recurrence of infection during the follow-up period, were defined as having a full secondary response. Full details of the trial are provided in the protocol and the statistical analysis plan, available at NEJM.org.

Figure 1.Results of Fecal Microbiota Transplantation versus Antibiotic Therapy with Metronidazole for Primary Clostridium difficileInfection.

The paper, https://www.nejm.org/doi/full/10.1056/NEJMc1803103