Probiotics in Pediatric Diarrhea in Peru

秘鲁益生菌治疗小儿腹泻

• 批准号: 7691768
• 负责人: RICHARD A OBERHELMAN
• 金额: $ 53.64万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7691768
• 关键词: 5 year old; Acute; Address; Adverse event; Age; Antibiotic Therapy; Area; Bacteria; Bifidobacterium bifidum; Breast Feeding; Campylobacter; Cause of Death; Cessation of life; Child; Child health care; Childhood; China; Chronic; Clinical; Clinical Management; Clinical Treatment; Clinical Trials; Communities; Developed Countries; Developing Countries; Development; Diarrhea; Disease; Double-Blind Method; Environment; Etiology; Europe; Evaluation; Feces; Food Supplements; Frequencies; Giardia; Guidelines; Incidence; Intestines; Lactobacillus; Life; Malnutrition; Monitor; Morbidity - disease rate; Multi-Drug Resistance; Nutritional status; Oral Rehydration Therapy; Organism; Outcome; Participant; Pathology; Patients; Peer Review; Peru; Pharmacologic Substance; Placebos; Population; Probiotics; Protocols documentation; Public Health; Randomized; Relative (related person); Research; Role; Rotavirus; Rural Community; Safety; Shigella; Specimen; Testing; Time; Treatment Efficacy; United States; Viral; Virus; age group; base; burden of illness; cohort; community setting; double-blind placebo controlled trial; efficacy evaluation; enterotoxigenic Escherichia coli; gastrointestinal system; improved; microbial community; microorganism; mortality; pathogen; programs; randomized placebo controlled trial; resistant strain; treatment strategy

DESCRIPTION (provided by applicant): Diarrhea causes a billion illness episodes and 2.5 million deaths/year in children under the age of 5 years in the developing world and China, making it the second most frequent cause of death in this age group. Despite this burden of disease, the clinical management of diarrhea has remained largely stagnant since the development of oral rehydration therapy over thirty years ago. Multiple small studies have demonstrated the efficacy of probiotic agents, or beneficial bacteria used to colonize the gut, for improving the clinical course of diarrheal illness in children. However limitations of these small studies, done in areas where diarrhea is caused predominantly by viral pathogens in well nourished children, limit the relevance of these studies in areas where diarrhea remains a serious threat to child health. We propose to evaluate the relative efficacy of Lactobacillus GG (LGG) and Bifidobacterium bifidum (Bb), two promising probiotic agents, in a randomized double-blinded placebo-controlled trial for the treatment of diarrhea at the community level in Santa Clara, a town in the Peruvian Amazon where chronic malnutrition and childhood diarrhea are highly endemic. Six hundred and fifty children ages 6 months to 6 years will be randomized to 3 groups, which will receive LGG, Bb, or placebo respectively for 5 days with each episode of diarrhea during the surveillance period. Diarrhea stool specimens will be examined for bacterial, viral, and parasitic pathogens. Our multiyear study will allow for the evaluation of treatment with these probiotic agents for all causes of diarrhea and on specific prevalent causes of pediatric diarrhea such as rota virus, enterotoxigenic E. coli, Shigella, Giardia and Campylobacter. Episode-specific outcomes such as time to last unformed stool, and subject-specific outcomes, including overall burden of disease, frequency of adverse events, and changes in nutritional status overtime, will be compared between treatment groups. Intensive study of a longitudinal cohort with stringent monitoring of adverse events will allow us to address many unanswered questions, such as the impact of breastfeeding and malnutrition on therapeutic efficacy and strategies for acceptance of the new therapies. The proposed project will allow for a critical and thorough evaluation of the efficacy, practicality, and safety of probiotic organisms in a developing country, where children continue to suffer high burdens of diarrheal diseases and are in need of new and improved approaches to treatment.

描述（由申请人提供）：在发展中国家和中国，腹泻会导致50岁以下儿童的疾病发作和250万人死亡，这使其成为该年龄段的第二大死亡原因。尽管有这种疾病的负担，但自三十年前口服补液疗法的发展以来，腹泻的临床管理仍在很大程度上停滞不前。多项小型研究表明，用于改善儿童腹泻病的临床疗程的益生菌剂或用于定居肠道的有益细菌的功效。然而，这些小型研究的局限性在腹泻造成的腹泻，主要是由良好滋养的儿童引起的腹泻，限制了这些研究在腹泻仍然对儿童健康构成严重威胁的地区的相关性。我们建议在一项随机的双眼安慰剂对照试验中评估两种有前途的益生菌剂的乳酸杆菌（LGG）和双歧杆菌双歧杆菌（BB）的相对疗效，以治疗佩利维亚·亚马逊（Peruvian Amazon）的较高症状和儿童养育者，以治疗社区层的腹泻。 6个月至6岁的6个年龄六十五个儿童将随机分为3组，在监视期间，每个腹泻的每集分别将分别接受LGG，BB或安慰剂。将检查细菌，病毒和寄生病原体的腹泻粪便标本。我们的多年研究将允许用这些益生菌剂对所有腹泻的原因以及小儿腹泻的特定原因进行评估。在治疗组之间，将比较特定于发作的结果，例如时间持续的粪便进行最后的未成熟粪便和特定主题的结果，包括疾病的整体负担，不良事件的频率以及营养状况的随着时间的加班而变化。对纵向队列进行严格监控的深入研究将使我们能够解决许多未解决的问题，例如母乳喂养和营养不良对治疗功效的影响以及接受新疗法的策略。拟议的项目将允许对发展中国家的益生菌生物的功效，实用性和安全性进行严格的评估，在那里，儿童继续遭受腹泻疾病的高负担，并且需要新的和改进的治疗方法。