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

Award Number: R43GM146506
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2024

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Stabilization of therapeutic microbes for inclusion in a liquid matrix for delivery to the intestines - Project Summary/Abstract Enteral feeding (EF) is an essential medical procedure used to supply nutrients directly to the gastrointestinal (GI) tract of patients who are unable to eat independently. EF formula is often purchased as a ready-to-use liquid that contains carbohydrates, protein, fats, and micronutrients to ensure adequate nutritional benefit for the patient. The addition of therapeutic probiotics to EF formula has been shown to improve patient health and recovery, while reducing the cost burden to patients and hospitals. However, specific challenges remain which have prevented widespread use. These include: an instability of probiotics in nutrient rich, complex liquid mediums, including high fat, salt, or sugar liquids and biphasic systems such as emulsions and collo ids, a narrow list of compatible probiotics with marginal therapeutic benefit, a risk of cross-contamination during handling/reconstitution of powder probiotics, sedimentation/aggregation of probiotics, causing blockage of the feeding tube, inactivation of the probiotics by the acidic stomach environment, and a lack of proper adhesion and growth in the gastrointestinal tract. A platform drug delivery technology which encapsulates cells and stabilizes the compounds during storage and digestion while facilitating both mucoadhesion and direct growth on intestinal surfaces has previously been developed and will be optimized for use in liquid EF nutritional formula in this proposal. Lactobacillus rhamnosus HN001, a microbe reported to support gut health and the immune system, will be coated with the platform technology and evaluated for performance and shelf life stability in a complex liquid EF formula. Furthermore, multiple excipients with moisture barrier features will be explored in an effort to extend the liquid shelf life stability.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	VITAKEY INC	1222 16TH ST NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Biomedical Research and Research Training	000	1	6/26/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $295,924 )
2023	2023	VITAKEY INC	1222 16TH ST NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Biomedical Research and Research Training	000	1	1/26/2023	NEW	$295,924
														Subtotal = $295,924

Grand Total All Awards = $295,924

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

Award Number: R43GM146506

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2024

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