Safety and Efficacy of Probiotics in Bangladeshi Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Presence of probiotic in the stool
研究概览
简要总结
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants.
- •Infants 1 -3 months of age at the beginning of the study.
- •Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
- •Parents and child are planning to remain in Dhaka for the next four months.
排除标准
- •Infants with known birth defects.
- •Infants who have been hospitalized.
- •Infants who have an acute infection or illness at the time of enrolment.
- •Infants who are currently taking antibiotics
- •Infants <1 month of age or >3 months of age.
- •Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
- •Infants who are already receiving a probiotic product or treatment.
- •A diagnosis or suspicion of immunodeficiency disorder.
- •A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- •Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
结局指标
主要结局
Presence of probiotic in the stool
时间窗: weeks 0-12
presence of absence of each probiotic in the stool
Adverse events
时间窗: duration of study - through study completion
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
次要结局
- growth(month 0, 1, 2, 3)
- composition of microbiota(weeks 0-12)
- gut function(months 0, 1, 2, 3)
- quantity of probiotic in the stool(weeks 0-12)
- clinical effects(daily for 7 days after first probiotic administration, then weeks 2-12)
- gut inflammation/translocation(months 0, 1, 2, 3)
- breastfeeding rates(month 0, 1, 2, 3)
- gut inflammation(months 0,1,2,3)
研究者
Julie Parsonnet
Principal Investigator
Stanford University