Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection

BMC Medicine

Research Article

Joanne Levin¹  Hamed Khalili²  Jenny Sauk³  Jess L. Kaplan⁴  Jasmin Mahabamunuge⁵  Hannah K. Systrom⁵  Ilan Youngster⁶  Elizabeth L. Hohmann⁷ 

[1] Cooley Dickinson Hospital, Northampton, MA, USA;Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA;Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Division of Pediatric Gastroenterology, Massachusetts General Hospital for Children, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Divisions of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA;Divisions of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA;Division of Infectious Diseases, Boston Children’s Hospital, 300 Longood Ave, 02115, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Divisions of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;

关键词: Fecal microbiota transplant;    Clostridium difficile;    Microbiome;    Oral administration;   

DOI  :  10.1186/s12916-016-0680-9

 received in 2016-07-04, accepted in 2016-08-25,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundFecal microbiota transplantation (FMT) has been shown to be safe and effective in treating refractory or relapsing C. difficile infection (CDI), but its use has been limited by practical barriers. We recently reported a small preliminary feasibility study using orally administered frozen fecal capsules. Following these early results, we now report our clinical experience in a large cohort with structured follow-up.MethodsWe prospectively followed a cohort of patients with recurrent or refractory CDI who were treated with frozen, encapsulated FMT at our institution. The primary endpoint was defined as clinical resolution whilst off antibiotics for CDI at 8 weeks after last capsule ingestion. Safety was defined as any FMT-related adverse event grade 2 or above.ResultsOverall, 180 patients aged 7–95 years with a minimal follow-up of 8 weeks were included in the analysis. CDI resolved in 82 % of patients after a single treatment, rising to a 91 % cure rate with two treatments. Three adverse events Grade 2 or above, deemed related or possibly related to FMT, were observed.ConclusionsWe confirm the effectiveness and safety of oral administration of frozen encapsulated fecal material, prepared from unrelated donors, in treating recurrent CDI. Randomized studies and FMT registries are still needed to ascertain long-term safety.

【 授权许可】

CC BY   
© The Author(s). 2016