Lactoferrin for the prevention of antibiotic-associated diarrhea in adult

描述(由申请人提供)：接受抗生素治疗的患者经常出现腹泻。在发达国家，成年人，特别是老年人，因腹泻而死亡的几率比儿童高。来自体外和体内初步研究的结果使我们假设口服重组人乳铁蛋白作为一种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第一阶段和第二阶段提案计划通过一项涉及260名受试者的临床试验来验证这一假设。在第一阶段，我们将从大米中生产25公斤的试验材料--重组人乳铁蛋白，同时获得IRB的临床试验批准。在第二阶段，我们将在巴尔的摩的四个试验点进行临床研究。我们预计，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%，如果患者真的腹泻，腹泻天数将缩短一半。 公共卫生相关性：与发达国家的儿童相比，成人腹泻的死亡率较高，这一点通常被忽视。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。

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.