IRCT20170201032346N3尚未招募3 期
Evaluation of Bifidobacterium Animalis Spp. Lactis oral suspension effect on crying/fussing time and changes of gut microbiota in formula-fed infants with colic: A Double blind randomized clinical trial
Ramsar Campus, Mazandaran University of Medical Sciences0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- no limit 至 49 days(—)
- 性别
- All
入选标准
- •exclusive formula feeding
- •less than 7 weeks of age
- •diagnosis of colic based on ROME IV criteria
- •accepting informed consent
排除标准
- •birth weight lower than 2500grams
- •preterm birth (Gestational age<37 weeks)
- •five minute Apgar score <7
- •breast feeding
- •Central venous catheter
- •severe medical condition
- •valvular heart disease
- •prematurity
- •reduction in growth or weight reduction of more than 100gram from birth to the last measurement
- •neurological disease
- •known of suspected food allergy
- •gastroesophageal reflux disease
- •Probiotic, prebiotic, antibiotic or acid suppressing agents in the past two weeks
- •history of fever or infectious disease in the past two weeks
- •progressive systemic infection
- •congenital infection
- •chronic bowel disease, e.g. cystic fibrosis and primary pancreatic insufficiency
- •primary or secondary digestive tract malformations, e.g. esophageal atresia, intestinal atresia, short bowel syndrome, malrotation
- •metabolic disease
- •genetic and chromosomal disease
- •primary or secondary immunodeficiency syndrome
- •suspecting noncompliance or caregiver's inability to act in accordance to the given protocol
- •previous participation in medical research
研究者
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