Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGSafety is assessed by clinical symptoms, exam, signs (GI and systemic).
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Time frame: Up to 3 months post-FMT
Efficacy
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
Time frame: Up to 3 months post-FMT
Change of fecal bacteriology
Fecal microbiology is characterized by 16S rRNA gene-based analysis.
Time frame: Up to 1 month post-FMT
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