2223. Stability and Efficacy of Frozen and Lyophilized Fecal Microbiota Transplant (FMT) Product in Mouse Model of Clostridium difficile Infection (CDI)
Session: Poster Abstract Session: Microbiome: GI
Saturday, October 29, 2016
Room: Poster Hall
Background: FMT is the most effective therapy of multiple recurrences of CDI. Fresh product delivered by colonoscopy is considered standard form of FMT. Frozen product is used more commonly but length of time for storage has not been established. In this study, we tested in vivofrozen and lyophilized products stored up to 15 months at -80°C (frozen) or 4°C (lyophilized) to determine the genus composition stability and efficacy in mouse model. Both products were obtained from healthy donors.

Methods: Mice challenged with 105 C. dfficile (ATCC43255) were divided into 4 groups (6 in each group). An untreated group of mice with CDI served as a control. The other groups of mice were treated with either fresh frozen or lyophilized product at the same storage period. Each of products (200µL) was administered by gavage 1 day after the challenged. The endpoint in the mouse challenge studies was diarrhea based on form of stools using a modified human Bristol Stool Chart.

Results: Diarrhea was documented in 21 of 25 (84%) mice in the CDI control group. None of the mice treated with fresh product or frozen/lyophilized products stored ≤ 7 months developed diarrhea. Efficacy decreased when frozen or lyophilized products stored > 7 months (P<0.0273). There was no significant difference between frozen and lyophilized products (P=0.8298) with the same storage months. Donation products were analyzed using quantitative real-time PCR (qPCR) to determine bacterial genera immediately after processing and 9 months after storage. qPCR analysis demonstrated a significant 1.6 fold decrease (p=0.02) in concentrations of fecal Bifidobacteria species in frozen or lyophilized comparing to fresh FMT products after 9 months stored at -80°C/4°C. The diversity for Bacteriodetes, E. coli and Lactobacillusin the fresh, frozen and lyophilized products were statistically different with lower counts of these genera in lyophilized samples after 9 months storage at 4°C (p=0.0060, p=0.0026, and p=0.0003 respectively).

Conclusion: Our data showed both frozen and lyophilized products remained stable in vivo in terms of mouse protection from CDI after 7 months storage. qPCR results demonstrated that microbial content was different after 9 months storage among fresh, frozen and lyophilized samples. Frozen and lyophilized products have a limited storage time.

Zhi-Dong Jiang, MD, DrPH, The University of Texas Houston School of Public Health, Houston, TX, Herbert Dupont, MD, FIDSA, St. Luke's Hospital and Kelsey Research Foundation and Kelsey-Seybold Clinic, Houston, TX, Shi Ke, MD, Center for Infectious Diseases, The University of Texas School of Public Health, Houston, TX and Ashley Alexander, MHSA, Kelsey Research Fundation, Houston, TX

Disclosures:

Z. D. Jiang, None

H. Dupont, None

S. Ke, None

A. Alexander, None

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