Format

Send to

Choose Destination
BMC Infect Dis. 2015 Apr 17;15:191. doi: 10.1186/s12879-015-0930-z.

Effectiveness of fecal-derived microbiota transfer using orally administered capsules for recurrent Clostridium difficile infection.

Author information

1
The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. bhirsch@nshs.edu.
2
The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. nsaraiya13@nshs.edu.
3
The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. kpoeth@nshs.edu.
4
Department of Population Health, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, Manhasset, New York, USA. rschwartz3@nshs.edu.
5
The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. mepstein@nshs.edu.
6
Symbiotic Health Inc., New York, New York, USA. ghonig@symbioticbio.com.

Abstract

BACKGROUND:

Clostridium difficile infection (CDI), a complication of antibiotic-induced injury to the gut microbiome, is a prevalent and dangerous cause of infectious diarrhea. Antimicrobial therapy for CDI is typically effective for acute symptoms, but up to one third of patients later experience recurrent CDI. Fecal-derived microbiota transplantation (FMT) can ameliorate the underlying dysbiosis and is highly effective for recurrent CDI. Traditional methods of FMT are limited by patient discomfort, risk and inefficient procedures. Many individuals with recurrent CDI have extensive comorbidities and advanced age. Widespread use of FMT requires strategies that are non-invasive, scalable and applicable across healthcare settings.

METHODS:

A method to facilitate microbiota transfer was developed. Fecal samples were collected and screened for potential pathogens. Bacteria were purified, concentrated, cryopreserved and formulated into multi-layered capsules. Capsules were administered to patients with recurrent CDI, who were then monitored for 90 days.

RESULTS:

Thirteen women and six men with recurrent CDI were provided with microbiota transfer with orally administered capsules. The procedure was well tolerated. Thirteen individuals responded to a single course. Four patients were cured after a second course. There were 2 failures. The cumulative clinical cure rate of 89% is similar to the rates achieved with reported fecal-derived transplantation procedures.

CONCLUSIONS:

Recurrent CDI represents a profound dysbiosis and a debilitating chronic disease. Stable cure can be achieved by restoring the gut microbiome with an effective, well-tolerated oral capsule treatment. This strategy of microbiota transfer can be widely applied and is particularly appropriate for frail patients.

PMID:
25885020
PMCID:
PMC4506624
DOI:
10.1186/s12879-015-0930-z
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center