NCT02745327已完成不适用
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Glucose-Hydrogen Breath Test
研究概览
简要总结
The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously)
- •Mother willing to sign informed consent form.
- •Healthy infant aged less than 7 days old
排除标准
- •Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed.
- •History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.
结局指标
主要结局
Glucose-Hydrogen Breath Test
时间窗: Birth to 2 years
Test for Small Intestine Bacterial Overgrowth
次要结局
- Fecal Myeloperoxidase(Birth to 2 years)
- Serum Cobalamin(Birth to 2 years)
- Serum Albumin(Birth to 2 years)
- Serum Tetanus antibody titers(Birth to 2 years)
- Height(Birth to 2 years)
- Head circumference(Birth to 2 years)
- Serum 25-OH vitamin D(Birth to 2 years)
- Serum Zinc(Birth to 2 years)
- Serum Retinol Binding Protein(Birth to 2 years)
- Oral fluid Tetanus antibody titers(Birth to 2 years)
- Weight(Birth to 2 years)
- Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)(Birth to 2 years)
- Lactulose mannitol ratio(12 weeks of age)
- Serum Polio antibody titers to sabin strains(Birth to 2 years)
研究者
William Petri, MD
Division Chief, Infectious Disease
University of Virginia
研究点 (1)
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