CTRI/2025/07/091827尚未招募Phase 3 4
Efficacy of Supplementing Oral Probiotics to Breastfeeding Mothers on Neonatal Weight
K Manikandan Arunasalam1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年8月11日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- change in neonatal weight gain
研究概览
简要总结
Maternal probiotic supplementation during lactation significantly enhances neonatal weight gain in the early postnatal period. This intervention is a safe, non-invasive, and potentially cost-effective strategy to promote optimal growth in exclusively breastfed infants. Further large-scale studies are needed to confirm these findings and evaluate long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy breastfeeding mothers (aged 18 to 40 years) of Full term neonates with a birth weight of more than or equal to 2.5 kg.
- •Exclusive breastfeeding commitment for at least one months.
排除标准
- •Maternal antibiotic use within the last two weeks.
- •Preterm neonates or those with congenital anomalies.
- •Mothers with significant medical conditions (e.g., diabetes, hypothyroid, autoimmune diseases).
结局指标
主要结局
change in neonatal weight gain
时间窗: Baseline and 30 days.
次要结局
- To evaluate the effect of probiotics in preventing Neonatal Hyperbilirubinemia (NNH), and Necrotising Enterocolitis (NEC)(6 to 9 months)
研究者
K Manikandan Arunasalam
Chettinad Hospital and Research Institute
研究点 (1)
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