NCT03081936已完成4 期
Comparative Effects of A1 Versus A2®Cow Milk Based Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant: a Pilot Double-blinded, Randomized, Controlled Parallel Study
a2 Milk Company Ltd.0 个研究点目标入组 33 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Stool frequency
研究概览
简要总结
This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion. The impact of the study products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and infant growth were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to formula feeding and consume 600ml or more of IF each day;
- •Have normal electrocardiograms (ECG) and blood pressure during quiet respiration.
- •Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
- •Parent(s) or legal guardian's consent to the study and willing to comply with study procedures;
- •Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study;
- •Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
排除标准
- •Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
- •During pregnancy, the mothers had pregnancy complications or other disease that may affect the results;
- •Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other disease;
- •Having neonatal diarrhea or acute respiratory infections within 48hours before enrollment;
- •Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
- •Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment;
- •Body weight-to-height Z-value <-3 according to the standard of the World Health Organization (WHO);
- •Receiving hormone therapy and intravenous nutrition;
- •Lactose intolerance or allergic to ingredients of study product;
- •Have history of faecal impaction;
- •Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
- •Currently taking medicines for cardiovascular or metabolic disease ;
- •Currently suffering from any gastrointestinal disorders or gastrointestinal disease , including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
- •Had hospitalizations within 3 months before screening;
- •According to investigator's judgment, current frequent users of drugs which may affect the gastrointestinal function or immune system;
- •Unable to comply the study schedule.
结局指标
主要结局
Stool frequency
时间窗: Baseline, Week 8
Change from Baseline weekly average of the number of defecation per day at 8 weeks
次要结局
- Fecal microflora counts(Baseline, Day 7, Day 56)
- Stool color(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Fecal Myeloperoxidase (MPO) concentration(Baseline, Day 7, Day 56)
- Fecal Short Chain Fatty Acid (SCFA) concentration(Baseline, Day 7, Day 56)
- Stool consistency(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Fecal sIgA concentration(Baseline, Day 7, Day 56)
- Body weight(Baseline, Day 7, Day 56)
- Body height(Baseline, Day 7, Day 56)
- Head circumstance(Baseline, Day 7, Day 56)
- Chest circumstance(Baseline, Day 7, Day 56)
- Sleep duration(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Milk regurgitation frequency(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Cry frequency(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Cry duration(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
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