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Lactoferrin for the prevention of antibiotic-associated diarrhea in adult

乳铁蛋白用于预防成人抗生素相关性腹泻

基本信息

批准号：
8323230
负责人：
NING HUANG
金额：
$ 42.08万
依托单位：
VENTRIA BIOSCIENCE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-15 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8323230
关键词：
Abdominal Cramps Adult Age-Years Anti-Inflammatory Agents Anti-inflammatory Antibiotic Therapy Antibiotics Baltimore Biochemical Candida Carbohydrates Case Report Form Cause of Death Cereals Cessation of life Child Clinical Clinical Protocols Clinical Research Clinical Trials Clostridium Clostridium difficile Colitis Cytotoxin Death Rate Dehydration Developed Countries Diarrhea Dietary Intervention Digestion Disease Dose Effectiveness Elderly Enterotoxins Equilibrium Feces Fever Food Safety Gastroenteritis Grant Growth Hospitalization Human Human Milk Immunology In Vitro Incidence Infection Inflammatory Informed Consent Institutional Review Boards Interleukin-6 Intestinal Mucosa Intestines Klebsiella pneumonia bacterium Lactoferrin Lead Leukocytes Leukocytosis Life Long-Term Care Lung Mammalian Cell Marketing Materials Testing Metabolic Metronidazole Microbe Milk Proteins Morbidity - disease rate Nursing Homes Oral Oral Administration Osmosis Pamphlets Patients Peripheral Persons Phase Play Population Prevention Printing Probiotics Production Proteins Recombinants Research Design Research Personnel Rice Risk Factors Role Sepsis Shipping Ships Site Small Business Innovation Research Grant Social Impacts Societies Sodium Staphylococcus aureus Surveys Technology Test Result Testing Time Toxic effect Toxin Tumor Necrosis Factor-alpha Update Vancomycin Viral Volatile Fatty Acids Water Wound Healing absorption age group antimicrobial base cell growth cell motility clinical research site cytokine economic impact experience gut microflora human TNF protein in vivo medical food mortality neglect pathogen prevent public health relevance repaired

项目摘要

DESCRIPTION (provided by applicant): Patients treated with antibiotics frequently develop diarrhea. In developed countries, adults, particularly the elderly, experience a higher death rate due to diarrhea than children. Results from in vitro and preliminary in vivo studies lead us to hypothesize that oral administration of recombinant human lactoferrin as a medical food might be able to prevent and reduce antibiotic associated diarrhea in adults. The present fast track SBIR Phase I and II proposal plans to test this hypothesis with a clinical trial involving 260 subjects. In phase I, we will produce 25 kg of testing materials, recombinant human lactoferrin, from rice grain and at the same time obtain IRB approval of the clinical trial. In phase II, we will conduct the clinical study in four test sites in Baltimore. We expect that the study will prove that recombinant human lactoferrin is able to reduce incidence of antibiotic associated diarrhea by 50% and if patients do get diarrhea, the diarrhea days will be shorten by half. PUBLIC HEALTH RELEVANCE: The high death rate associated with diarrhea in adults compared to that in children in developed countries is commonly neglected. Oral administration of recombinant human lactoferrin might be able to prevent antibiotic associated diarrhea in adults and the present proposal is to test this hypothesis.

描述（由申请人提供）：接受抗生素治疗的患者经常发生腹泻。在发达国家，成人，特别是老年人，因腹泻而死亡的比例高于儿童。体外和初步体内研究的结果使我们假设，口服重组人乳铁蛋白作为医疗食品可能能够预防和减少成人抗生素相关性腹泻。目前的快速通道SBIR I期和II期提案计划通过涉及260名受试者的临床试验来测试这一假设。在第一阶段，我们将从大米中生产25公斤的测试材料重组人乳铁蛋白，同时获得IRB对临床试验的批准。在第二阶段，我们将在巴尔的摩的四个试验中心进行临床研究。我们期望这项研究将证明重组人乳铁蛋白能够将抗生素相关性腹泻的发生率降低50%，如果患者确实腹泻，腹泻天数将缩短一半。公共卫生关系：在发达国家，与儿童相比，成人腹泻相关的高死亡率通常被忽视。口服重组人乳铁蛋白可能能够预防成人抗生素相关性腹泻，目前的建议是验证这一假设。