Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial.

ABSTRACT:

Background

Fecal microbiota transplantation (FMT) via colonoscopy or enema has become a commonly used treatment of recurrent C. difficile infection (CDI).

Aims

To compare the safety and preliminary efficacy of orally administered lyophilized microbiota product compared with frozen product by enema.

Methods

In a single center, adults with ≥ 3 episodes of recurrent CDI were randomized to receive encapsulated lyophilized fecal microbiota from 100-200 g of donor feces (n = 31) or frozen FMT from 100 g of donor feces (n = 34) by enema. Safety during the three months post FMT was the primary study objective. Prevention of CDI recurrence during the 60 days after FMT was a secondary objective. Fecal microbiome changes were examined in first 39 subjects studied.

Results

SUBMITTER: Jiang ZD 

PROVIDER: S-EPMC6214502 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature