Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection

Abstract

See Covering the Cover synopsis on page 1225. BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridium difficile infection (rCDI). We performed a single-center randomized trial to compare the effects of FMT with those of fidaxomicin and vancomycin. METHODS: We studied consecutive adults with rCDI seen at a gastroenterology clinic in Denmark from April 5, 2016 through June 10, 2018. Patients were randomly assigned to a group that received FMT, applied by colonoscopy or nasojejunal tube, after 4-10 days of vancomycin (125 mg 4 times daily; FMTv; n ¼ 24), 10 days of fidaxomicin (200 mg twice daily; n ¼ 24), or 10 days of vancomycin (125 mg 4 times daily; n ¼ 16). Patients who had rCDI after this course of treatment and patients who could not be randomly assigned to groups were offered rescue FMTv. The primary outcome was combined clinical resolution and a negative result from a polymerase chain reaction test for Clostridium difficile (CD) toxin 8 weeks after the allocated treatment. Secondary end points included clinical resolution at week 8. RESULTS: All 64 patients received their assigned treatment. The combination of clinical resolution and negative results from the test for CD were observed in 17 patients given FMTv (71%), 8 patients given fidaxomicin (33%), and 3 patients given vancomycin (19%; P ¼ .009 for FMTv vs fidaxomicin; P ¼ .001 for FMTv vs vancomycin; P ¼ .31 for fidaxomicin vs vancomycin). Clinical resolution was observed in 22 patients given FMTv (92%), 10 patients given fidaxomicin (42%), and 3 patients given vancomycin (19%; P ¼ .0002; P < .0001; P ¼ .13). Results did not differ significantly between patients who received FMTv as their initial therapy and patients who received rescue FMTv. There was 1 serious adverse event that might have been related to FMTv. CONCLUSIONS: In a randomized trial of patients with rCDI, we found the FMTv combination superior to fidaxomicin or vancomycin based on end points of clinical and microbiological resolution or clinical resolution alone. ClinicalTrials.gov, number NCT02743234; EudraCT, j.no 2015-003004-24.

Treatment of Recurrent Clostridium difficile Infection in an Immunocompromised Patient with Severe Neutropenia Not Responding to Standard Therapy

“…ere are no data on the rate of CDI recurrence in hemo-oncologic patients; therefore, we expect that 25% of those patients will experience recurrence within 60 days after the initial episode, as seen in all CDI patients. e risk increased to 45% after the first recurrence and 75% after multiple recurrences in nonhemo-oncologic patient populations [1,[4][5][6].…”

“…Clostridium difficile Infection (CDI) constitutes 20-30% of nosocomial antibiotic-associated diarrhea [1]. Only C. difficile producing toxins A and B are considered pathogenic and, therefore, clinically significant [2].…”

“…e real challenge with CDI is that 25% of patients will experience recurrence within 60 days after the initial episode. Moreover, the risk increases to 45% after the first recurrence and 75% after multiple recurrences [1,[4][5][6]. One of the most effective strategies in reducing the risk of CDI recurrence is fecal microbiota transplantation (FMT).…”

Probiotics in the Complex Treatment of Various Diseases of the Gastrointestinal Tract

“…При использовании антибиотиков нормальное соотношение микроорганизмов в кишечнике нарушается, а вместе с тем нарушается барьерная функция микробиоты. Слепое рандомизированное исследование, проведенное с апреля 2016 по июнь 2018 года, показало в 71 % случаев положительную динамику в отношении лечения рецидивов Clostridium difficile путем сочетания терапии ванкомицином с фекальной трансплантацией [3]. Для исследования была тщательно отобрана группа из 64 пациентов старше 18 лет с данными рецидивов инфекции Clostridium difficile в течение как минимум 8 недель после окончания курса приема антибиотиков, с жидким стулом не меньше 3 раз в день (6-7-го типа по классификации Bristol).…”

Banking feces: a new frontier for public blood banks?

“…In modern medicine, the first successful FMTs were reported in 1958 by Eiseman and coworkers, who treated four patients with pseudomembranous colitis caused by Clostridioides (formerly Clostridium ) difficile (CD), which was unknown at that time. Since then, resolution rates of 70% to 90% following FMT for recurrent CD infection (rCDI) have been consistently reported in both observational studies and randomized trials …”