NCT02406937已完成4 期
Efficacy of New Stage 1 Formula on the Improvement of Gut Comfort and Gut Health
Heilongjiang Feihe Dairy Co. Ltd.1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Stool Frequency
研究概览
简要总结
180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups, including breast feeding, commercial and new formula group. Study intervention is 12 weeks.
详细描述
Primary objective:
- Improvement on gut health and infant comfort
Secondary objective：
- Efficacy on easy digestion;
- Changes on SCFA in feces(Baseline and Endpoint)
- Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)
- Changes on sIgA in feces(Baseline and Endpoint)
- Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;
- Incidence of eczema and duration;
- Infants growth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 7-90 days;
- •Fed by breast milk before enrollment;
- •Parent or legal guardian fully understand the purpose and requirement, including the potential risks and side effects of the study;
- •Willing to participate in the study and comply all the procedures;
- •Concent form signed by parents.
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;
- •Think about the need to exclude C-section delivered infants? It's often the majority of births in Chinese tier-1 cities, so it will probably make the study recruitment slower, and postpone the study. The microflora of C-section infants in known to be different compared to normally born infants. At least, the mode of delivery should be noted and calculated into the primary and secondary outcome measurements as a potential confounding factor
- •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;
- •Having gluten allergy (celiac disease);
- •Body weight-to-height Z-value<-3 according to the standard of WHO;
- •Receiving hormone therapy and intravenous nutrition;
- •Lactose intolerance or allergic to ingredients of study product;
- •Have participated in other clinical studies within 3 months prior to the date of screening;
- •Unable to comply the study schedule.
研究组 & 干预措施
Feihe New Formula
Experimental
Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
干预措施: Oral intake of Feihe New Formula (Dietary Supplement)
Feihe Stage 1 Formula
Active Comparator
Oral intake of Feihe stage 1 formula
干预措施: Oral intake of Feihe Stage 1 Formula (Dietary Supplement)
Breast Feeding
Placebo Comparator
Oral intake of breast milk
干预措施: Breast Feeding (Dietary Supplement)
结局指标
主要结局
Stool Frequency
时间窗: Baseline, Week 4, Week 8, Week 12
Average daily stool frequency during the measurement week
次要结局
- Number of Participants With Gastrointestinal Symptoms(Weekly (Baseline to Day 84))
- Stool Consistency(Baseline, Week 4, Week 8, Week 12)
- Crying Time(Baseline, Week 4, Week 8, Week 12)
- Fecal Concentration of Short Chain Fatty Acid(Baseline, Day 21)
- Body Length(Baseline, Day 28, Day 56, Day 84)
- Number of Participants With Eczema(Throughout the study period (84 days))
- Fecal Laboratory Detection for sIgA(Baseline, Day 84)
- Fecal Bacterium Concentration(Baseline, Day 21)
- Eczema Duration(Throughout the study period (84 days))
- Body Weight(Baseline, Day 28, Day 56, Day 84)
- Head Circumference(Baseline, Day 28, Day 56, Day 84)
- Chest Circumference(Baseline, Day 28, Day 56, Day 84)
- Milk Regurgitation Frequency(Baseline, Week 4, Week 8, Week 12)
- Milk Feeding Quantity(Baseline, Week 4, Week 8, Week 12)
- Sleeping Time(Baseline, Week 4, Week 8, Week 12)
- Body Mass Index (BMI)(Baseline, Week 4, Week 8, Week 12)
研究者
研究点 (1)
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