*EMBARGOED All research presented at the ACG Annual Scientific Meeting is strictly embargoed until Monday, October 17, 2016 at 8:00 am EDT.
Poster 589 Encapsulated Lyophilized Fecal Microbiota Therapy for the Treatment of Clostridium difficile Infection
Author Insight from Scott Mitchell, Bsc (BiomedSc) (Hons.), The Centre for Digestive Diseases
What’s new here and important for clinicians?
Encapsulated lyophilized fecal microbiota therapy (FMT) has demonstrated many benefits over previous delivery methods such as enema, transcolonscopic and naso-enteric delivery. A key advantage of our capsules which contain concentrated bacteria is that their use is not merely for the treatment of Clostridium difficile infection (CDI), but for ongoing dosing in the treatment of non-CDI indications, which do not reverse after a short treatment. Recent studies have explored the use/efficacy of encapsulated FMT for the treatment of CDI using material derived from frozen whole stool,[i] filtered frozen stool,[ii] and frozen spores.[iii] These studies required patients to consume a high number e.g., 30, of capsules,[ii] and patients with esophageal disorders were excluded. Additionally, the capsules needed to remain frozen and a specialized “cold chain” transport system was required.
Our FMT product is a highly filtered, dry, concentrated, low-volume, high-viability capsule that can be stored without freezing. It has achieved CDI clinical cure even with a small number of capsules during treatment. Additional advantages to our encapsulated lyophilized FMT include:
- More aesthetically appealing than liquid or frozen alternatives;
- Able to traverse both the small and large intestine;
- When stored at room temperature, there is no significant decrease in viability when compared with fresh or thawed frozen stool;
- Able to be transported without specialized deep freezing;
- Targeted patient delivery (i.e., for a specific condition); and
- Encapsulated FMT product can be easily quarantined for safety until pathology screening is performed.
What do patients need to know?
The non-invasive nature of encapsulated lyophilized FMT makes it the most patient friendly method of administration. Current studies are investigating the potential of FMT in the treatment of non-CDI indications, such as ulcerative colitis.
Scott Mitchell, Bsc (BiomedSc) (Hons.), The Centre for Digestive Diseases
Prathibha De Zoysa, MPH (Sydney), BSc (BioSc), FRSPH, The Centre for Digestive Diseases
[i] Bakken J, Borody T, Brandt L, et al. Treating Clostridium difficile Infection With Fecal Microbiota Transplantation. Clinical Gastroenterology and Hepatology. 2011;9:1044-1049.
[ii] Fecal Microbiota Transplantation Delivered via Oral Capsule Achieves Microbial Engraftment Similar to Traditional Delivery Modalities: Safety, Efficacy and Engraftment Results From a Multi-Center Cluster Randomized Dose-Finding Study (OpenBiome).
[iii] Khanna S, Pardi D, Kelly C, et al. A Novel Microbiome Therapeutic Increases Gut Microbial Diversity and Prevents Recurrent Clostridium difficile Infection. J Infect Dis. 2016; 214(2): 173-181.
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