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临床试验/IRCT20170201032346N3
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

发起方
Ramsar Campus, Mazandaran University of Medical Sciences

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