NCT01893814终止2 期
Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Probi AB
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Reduction of abdominal discomfort as assessed by comparison of crying time
研究概览
简要总结
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female singleton
- •≥ 2 weeks and ≤ 12 weeks of age
- •Exclusively breastfed at screening
- •Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
- •Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
- •Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study
- •Born at full term (37-42 after last menstruation period)
- •Birth weight: 2500 - 4500 g
- •Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts
- •Apparently healthy at birth (Apgar ≥ 8) and at screening visit
- •No major complications during pregnancy or at birth
- •Mother 19-45 years of age at childbirth
- •Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires
排除标准
- •Intolerance to investigational product/its ingredients
- •Severe medical condition or illness, congenital abnormality
- •Gastrointestinal disorders (e.g. reflux esophagitis)
- •Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
- •Formula feeding at screening/randomisation
- •Allergy or atopic disease (family history)
- •Participation in another study
- •Mother's health condition that may interfere with her ability to take care of her infant
- •Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome
- •Use of antibiotics by the mother in the week
结局指标
主要结局
Reduction of abdominal discomfort as assessed by comparison of crying time
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (2)
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