ISRCTN13340073已完成不适用
The efficacy of 3 weeks supplementation with a probiotic dietary supplement on infant colic: a randomized, double-blind, placebo-controlled, parallel group study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
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
- 性别
- All
入选标准
- •1. Infant colic defined as 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 III)
- •2. Exclusive breast fed infants at inclusion
- •3. Less than 3 months of age
- •4. Greater than 37 weeks gestation at birth
- •5. Birth weight of more than 2500 g
排除标准
- •1. Formula fed or combination breast fed/ formula fed infants
- •2. Failure to thrive (weight gain < 100 grams/week averaged from birth to the last recorded weight)
- •3. Major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality
- •4. Gastrointestinal disorder
- •5. Taking antibiotics four weeks prior to enrollment
- •6. Using probiotics in the past two weeks prior to enrollment
- •7. Taking antibiotics during intervention
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