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临床试验/NCT07615842
NCT07615842尚未招募1 期

Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants

University of Virginia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
150
试验地点
1

研究概览

简要总结

The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40/41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40/41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
6 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • presenting with diarrheal symptoms
  • age under 1 year
  • enrolled in study NCT02764918

排除标准

  • unwilling to give blood and stool samples

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Petri, MD, PhD

Principle Investigator

University of Virginia

研究点 (1)

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