A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: a randomized clinical trial

B. D. Huttner*, V. de Lastours, M. Wassenberg, N. Maharshak, A. Mauris, T. Galperine, V. Zanichelli, N. Kapel, A. Bellanger, F. Olearo, X. Duval, L. Armand-Lefevre, Y. Carmeli, M. Bonten, B. Fantin, S. Harbarth, L. Colle, F. Kloosterman, W. van Bentum-Puijk, J. VlooswijkA. Andremont, M. Ben Hayoun, E. Canoui, A. Chabrol, N. Gamany, M. Lafaurie, A. Lefort, R. Lepeule, Z. Louis, E. Rondinaud, H. Sadou-Yaye, L. Sarfati, V. Zarrouk, C. Brossier, L. Carrez, V. Lazarevic, G. Renzi, E. von Dach, S. Cohen Percia, R. Shvartz, J. Lellouche

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Objectives: Intestinal carriage with extended spectrum β-lactamase Enterobacteriaceae (ESBL-E) and carbapenemase-producing Enterobacteriaceae (CPE) can persist for months. We aimed to evaluate whether oral antibiotics followed by faecal microbiota transplantation (FMT) can eradicate intestinal carriage with ESBL-E/CPE. Methods: Randomized, open-label, superiority trial in four tertiary-care centres (Geneva (G), Paris (P), Utrecht (U), Tel Aviv (T)). Non-immunocompromised adult patients were randomized 1: 1 to either no intervention (control) or a 5-day course of oral antibiotics (colistin sulphate 2 × 106 IU 4×/day; neomycin sulphate 500 mg 4×/day) followed by frozen FMT obtained from unrelated healthy donors. The primary outcome was detectable intestinal carriage of ESBL-E/CPE by stool culture 35–48 days after randomization (V4). ClinicalTrials.gov NCT02472600. The trial was funded by the European Commission (FP7). Results: Thirty-nine patients (G = 14; P = 16; U = 7; T = 2) colonized by ESBL-E (n = 36) and/or CPE (n = 11) were enrolled between February 2016 and June 2017. In the intention-to-treat analysis 9/22 (41%) patients assigned to the intervention arm were negative for ESBL-E/CPE at V4 (1/22 not receiving the intervention imputed as positive) whereas in the control arm 5/17 (29%) patients were negative (one lost to follow up imputed as negative) resulting in an OR for decolonization success of 1.7 (95% CI 0.4–6.4). Study drugs were well tolerated overall but three patients in the intervention group prematurely stopped the study antibiotics because of diarrhoea (all received FMT). Conclusions: Non-absorbable antibiotics followed by FMT slightly decreased ESBL-E/CPE carriage compared with controls; this difference was not statistically significant, potentially due to early trial termination. Further clinical investigations seem warranted.

Original languageEnglish
Pages (from-to)830-838
Number of pages9
JournalClinical Microbiology and Infection
Issue number7
StatePublished - Jul 2019


FundersFunder number
Faculty of Medicine, Geneva
Gal Schtrechman Levi
Shimrit Cohen Percia
Seventh Framework Programme282512
European Commission
Institut Pasteur
Seventh Framework Programme
Hôpitaux Universitaires de Genève
Institut de Veille Sanitaire


    • Carbapenemase
    • Colistin
    • Extended-spectrum β-lactamase
    • Faecal microbiota transplantation
    • Neomycin


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