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临床试验/ISRCTN92431452
ISRCTN92431452已完成未知

The efficacy of three weeks’ daily supplementation with two-combined probiotic strains on infant colic

Angel Children’s Hospital0 个研究点目标入组 112 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
112

研究概览

简要总结

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34568236/ (added 28/09/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Crying or fussing episodes lasting more than 3 hours per day and occurring at least 3 days per week within 7 days prior to enrollment (ROME IV criteria)
  • 2. Less than 3 months (12 weeks) of age
  • 3. Equal to or greater than 37 weeks of gestation at birth
  • 4. Vaginal delivery
  • 5. Birth weight of more than 2500g
  • 6. Provided voluntary written informed consent from parents of the infant

排除标准

  • 1. Average weight gain < 100 grams/week from birth to the last recorded weight
  • 2. Major medical problems (e.g. immunocompromised disease, major developmental or genetic abnormality)
  • 3. Gastrointestinal disorder
  • 4. Taking antibiotics four weeks prior to enrollment
  • 5. Using the same probiotic strains in this study two weeks prior to enrollment
  • 6. Taking antibiotics during the intervention

研究者

发起方
Angel Children’s Hospital

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