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Stabilization of therapeutic microbes for inclusion in a liquid matrix for delivery to the intestines

US · IL NIH grant open #nih-2R44GM146506-02

Summary

The project aims to stabilize therapeutic microbes (probiotics) for inclusion in a liquid enteral feeding (EF) matrix to treat antibiotic-associated diarrhea (AAD) in patients unable to orally ingest capsules.

What they want

Enteral feeding (EF) patients often experience antibiotic-associated diarrhea (AAD) due to simultaneous antibiotic dosing, with no current effective treatment. Probiotics offer a potential therapeutic strategy but suffer from degradation during storage and consumption, and current methods of adding them to EF formula are inconsistent and reduce viability. This project proposes to use VitaKey’s proprietary liquid- and EF-stable probiotic encapsulation platform, developed in Phase I, to customize and stabilize specific probiotic strains (Bacteroides fragilis, Lactobacillus acidophilus, and Lactobacillus plantarum). The work involves establishing mechanistic support in a mouse AAD model and developing formulations capable of withstanding pasteurization, achieving long-term shelf-stability, demonstrating clinically-relevant efficacy in a murine AAD model, and being suitable for scalable manufacturing.
Deliverables
  • Mechanistic support for stabilized probiotics evaluated in a mouse AAD model
  • Formulations capable of withstanding pasteurization during product manufacturing
  • Formulations attaining long-term shelf-stability
  • Formulations reaching clinically-relevant efficacy levels in a murine model of AAD
  • Formulations suitable for scalable manufacturing
Technical requirements
  • Use of VitaKey’s proprietary liquid- and EF-stable probiotic encapsulation platform
  • Customization for probiotic strains: Bacteroides fragilis, Lactobacillus acidophilus, and Lactobacillus plantarum
  • Formulations must withstand pasteurization
  • Formulations must attain long-term shelf-stability
  • Formulations must reach clinically-relevant efficacy levels in a murine model of AAD
  • Formulations must be suitable for scalable manufacturing

Risks & flags

Incumbent: VitaKey
  • Project explicitly states the use of 'VitaKey’s proprietary liquid- and EF-stable probiotic encapsulation platform developed in Phase I', indicating a specific vendor and technology are already selected or are the sole source for this work.
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