Role of Probiotics Administered as an Adjuvant Therapy in Pathological Neonatal Unconjugated Hyperbilirubinemia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.
研究概览
简要总结
Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.
详细描述
Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.
Phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.
Probiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.
排除标准
- •neonates who have kernicterus.
- •neonates who have ventilation problem.
- •neonates who have heart failure.
- •-neonates who have asphyxia.
- •neonates who have history of Rh incompatibility
研究组 & 干预措施
probiotics
will receive 5 drops of probiotic supplement containing Bacillus clausil spores (Enterogermania amp 2 billion/5 mL) once daily plus phototherapy till discharge.
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.
时间窗: up to 4 weeks
次要结局
- The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)(up to 4weeks)
研究者
Samah Safwat
Principal investigator
Tanta University