Effect of probiotic and zinc supplementation on systemic immune response to oral rotavirus and oral poliovirus vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- •To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo
研究概览
简要总结
This single center,double blind, double-dummy, placebo controlled, randomized parallel clinicaltrial with four groups will enroll approximately 560 total study participantsat approximately 5 weeks of age residing in proximity to the Christian MedicalCollege in Vellore. As part of theparallel design, study participants will be randomized to one of the fourgroups following a 1:1:1:1 allocation to receive zinc supplement and probiotic supplement(N=140), zinc supplement and probiotic placebo (N=140), zinc placebo andprobiotic supplement (N=140), or zinc placebo and probiotic placebo(N=140). Serum specimens collected at 6 and 14 weeks will be analyzed for anti-rotavirus IgA and for neutralizing antibodies to poliovirus type 3 in order to determine whether or not supplementation with probiotics and/or zinc can enhance the proportion of children who respond to oral vaccination by at least 15%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 35.00 Day(s) 至 41.00 Day(s)（—）
- 性别
- All
入选标准
- •â€¢Infants 35-41 days old.
- •â€¢Live in area under surveillance.
- •â€¢Current weight ≥3.2 kg.
- •â€¢No syndromic evidence of immunocompromise.
- •â€¢No prior illness requiring hospitalization.
- •â€¢No current medical condition as determined by medical doctor which precludes study involvement.
- •â€¢Available for follow up for duration of study (through approximately 14 weeks of age).
- •â€¢Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent.
排除标准
- •â€¢Child has history of atopic symptoms.
- •â€¢Child has a known digestive system defect.
- •â€¢Child has history of chronic diarrhea.
- •â€¢Child has received a prior dose of rotavirus vaccine.
- •â€¢Child has received a prior dose of polio vaccine (beyond the birth dose).
结局指标
主要结局
•To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo
时间窗: 4 weeks after the second dose of immunization
次要结局
- •To evaluate the serologic immune response to oral polio vaccine among Indian infants receiving zinc or probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral polio vaccine compared to those receiving a zinc or probiotic placebo(4 weeks after the second dose of immunization)