Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional characterization of anti-Cryptosporidium antibodies associated with protection
研究概览
简要总结
The purpose of this study is to explore the role of anti-parasite antibody in protection of children from the parasitic infection cryptosporidiosis. This work has the promise of identifying immune pathways important for protection from parasitic infections of the gut, and will help with designing a vaccine to prevent this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.
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
- •Mother willing to sign informed consent form.
- •Healthy infant
- •No obvious congenital abnormalities or birth defects.
- •Stable household with no plans to leave the area for the next one year.
排除标准
- •Parents are not willing to have child's blood drawn.
- •Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study.
- •Mother not willing to have blood drawn and breast milk extracted.
- •Parents not willing to have field research assistant in home two times per week.
- •History of seizures or other apparent neurologic disorders.
- •Infant has any sibling currently or previously enrolled in this study, including a twin.
结局指标
主要结局
Functional characterization of anti-Cryptosporidium antibodies associated with protection
时间窗: Birth until 4 years
Measure antibody isotype and subclass, mucosal (stool) vs systemic (plasma), complement fixation and opsonophagocytosis using bead-based multiplex immunoassays.
次要结局
- In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response(Birth until 4 years.)
- Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection(Birth to 4 years old)
- Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response(Through collection of blood specimens on day 0, 14 and 28 during acute infection.)
- Determination of maternal humoral response and impact on child infection/immunity(On enrollment (all) and 4 months (breast milk only).)
- Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens(Birth until 4 years.)
- Determine child anthropometric measures(Every 6 months until 4 years)
- Household sanitation questionnaire(At enrollment)
- Socioeconomic status questionnaire(At enrollment)
研究者
William Petri, MD, PhD
Division Chief, Infectious Disease
University of Virginia