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.
Public Health Relevance Statement: Project Narrative This proposal involves optimizing a drug delivery platform for stabilizing probiotics in a liquid for inclusion in an enteral feeding (EF) nutritional formula. Providing a complete nutritional supplement for EF applications inclusive of a probiotic will help maintain normal gut flora, may increase antimicrobial/immunological activity, suppress the colonization of the gut by enteropathogens, reduce diarrhea and assist in colonic water reabsorption due to presence of short-chain fatty acids. Furthermore, studies have shown significant medical benefits by adding probiotics to EF formulas including a faster return to normal gut function, reduced time on a ventilator, and reduced ICU hospital stays.
Project Terms: absorption; Acids; Adhesions; Oral Drug Administration; intraoral drug delivery; Oral Administration; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Elderly; Alginates; Desire for food; Appetite; beeswax; bile salts; Biopolymers; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; Carbohydrates; Carbon Dioxide; CO2; Carbonic Anhydride; Cells; Cell Body; Clinical Research; Clinical Study; Colloids; Colon; Critical Illness; Critically Ill; Deglutition Disorders; Dysphagia; Swallowing Disorders; Dextrans; dextran; Diarrhea; Digestion; Eating; Food Intake; Emulsions; Environment; Excipients; Fatty acid glycerol esters; Fats; Volatile Fatty Acids; Short-Chain Fatty Acids; Gastrointestinal tract structure; Alimentary Canal; Digestive Tract; GI Tract; Gastrointestinal Tract; alimentary tract; digestive canal; Glycerol; 1,2,3-Propanetriol; 1,2,3-Trihydroxypropane; Glycerin; Government; Growth; Generalized Growth; Tissue Growth; ontogeny; Health; Hospitalization; Hospital Admission; Hospitals; Immune system; Immunity; Intestines; Intestinal; bowel; Inulin; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Marketing; Modernization; Persons; Nursing Homes; nursing home; nutrition; Oxygen; O element; O2 element; Patients; Polysaccharides; Glycans; Powder dose form; Powders; Proteins; Risk; Sodium Chloride; salt; Stomach; gastric; Stroke; Apoplexy; Brain Vascular Accident; Cerebral Stroke; Cerebrovascular Apoplexy; Cerebrovascular Stroke; brain attack; cerebral vascular accident; cerebrovascular accident; stroked; strokes; Tannic Acid; Tannins; Technology; Temperature; Time; Water; Hydrogen Oxide; Drug Delivery; Drug Delivery Systems; enteric feeding; feeding tube; gastric feeding; tube feeding; Enteral Feeding; Ventilator; Poliglusam; Chitosan; improved; Procedures; Surface; Encapsulated; Phase; Medical; Ensure; Evaluation; disability; Recovery; sugar; diet supplement; nutritional supplement; dietary supplements; Micronutrients; Therapeutic; fluid; liquid; Liquid substance; Lactobacillus casei rhamnosus; L rhamnosus; L. rhamnosus; Lactobacillus rhamnosus; Deposition; Deposit; Electrostatics; Life; Investigation; Complex; Oral; microorganism; Techniques; System; Probiotics; experience; Performance; pasteurization; hazard; Nutrient; Reporting; preventing; prevent; Sedimentation process; sedimentation; Dryness; Nutritional; nutritious; Immunologics; Immunochemical Immunologic; Immunologic; Immunological; Immunologically; cost; anti-microbial; antimicrobial; Microbe; enteral pathogen; enteropathogen; intestinal pathogen; intestine pathogen; enteric pathogen; reconstitute; reconstitution; liquid formulation; GI microbiota; Gastrointestinal microbiota; enteric microbial community; enteric microbiota; gastrointestinal microbial flora; gut commensal; gut community; gut flora; gut microbe community; gut microbial community; gut microbial composition; gut microbial consortia; gut microbiotic; gut microflora; intestinal flora; intestinal microbes; intestinal microbiota; intestinal microflora; intestinal tract microflora; gut microbiota; Sterilization; nutrient absorption; probiotic therapeutic; probiotic treatment; probiotic therapy; Formulation; GI colonization; gastrointestinal tract colonization; intestinal colonization; gut colonization; intestinal mucosal barrier; intestinal barrier; gut health; homes; Home; manufacture; technology platform; technology system
