Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,750
- 试验地点
- 2
- 主要终点
- Change in cytokine responses from baseline at 9 months in TB and H. pylori antigen-induced PBMC before and after provider managed treatment of latent TB or helminth infection
研究概览
简要总结
This observational epidemiologic study with nested cross-sectional and longitudinal aims will evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent tuberculosis, intestinal helminthiasis) in recent US immigrants.
详细描述
1750 clinically-well, adult (age 18-55 years), recent immigrants (<2 years U.S. residence), referred through cooperating public health clinics in the Santa Clara Valley area, CA will be screened for H. pylori, helminth, and latent tuberculosis infections ["Screening" population]. Of these 1750, 426 will be selected for more intensive study (Cohort population), 105 of whom will receive baseline endoscopy. Of those selected for the cohort, 300 are expected to complete a 9-month follow-up assessment, 75 of whom are expected to undergo a second follow-up endoscopy.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18-55 years of age
- •Either sex
- •If female not pregnant or breastfeeding
- •Lived in the United States less than 2 years
- •Scheduled for Tuberculosis Skin Test (TST)
排除标准
- •Under 18 and older than 55 years of age,
- •Pregnant or breastfeeding
- •Have lived in Unites States more that 2 years
- •Chronic illness
- •Not planning to get a TST
结局指标
主要结局
Change in cytokine responses from baseline at 9 months in TB and H. pylori antigen-induced PBMC before and after provider managed treatment of latent TB or helminth infection
时间窗: Baseline and 9 months after treatment for either latent TB or helminth infections; analyzed after all subjects recruited (3 years of recruitment plus 9 months follow-up).
次要结局
- Correlation of cytokine response to TB antigens and helminths with humoral responses to infections with H. pylori.(Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.)
- Population prevalence of individual and joint infections with H pylori, latent tuberculosis, heminthiasis in recent immigrant to northern California(Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.)
研究者
Julie Parsonnet
Professor
Stanford University