Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bone density change from baseline (Tibial speed of sound measurement)
研究概览
简要总结
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with a 12-week intervention period.
The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6 months) milk powder on:
- Bone health;
- Infants growth;
- Intestinal health;
- Gastrointestinal tolerance to the test product;
g) Incidence of Eczema
详细描述
• Quality control of the study: 1.1 Study monitoring and source data verification: Monitoring was done according to the monitoring plan by a representative of the investigator, who checked the case report forms for completeness and clarity, and cross-checked them with source documents. In addition to the monitoring visits, frequent communications (letter, telephone, fax, e-mail), by the study monitor ensured that the investigation was conducted according to protocol design and regulatory requirements. Study close-out was performed by the study monitor upon closure of the study.
1.2 On-site audits: Domestic and foreign regulatory authorities, the IEC/IRB, and an auditor authorized by the sponsor may request access to all source documents, case report forms, and other study documentation for on-site audit or inspection. Direct access to these documents was guaranteed by the investigator, who must provide support at all times for these activities. Medical records and other study documents may be copied during audit or inspection provided that subject names are obliterated on the copies to ensure confidentiality.
1.3 Documentation: A case report form was provided for each subject. All protocol-required information collected during the study was entered by the investigator, or designated representative, in the case report form. Details of case report form completion and correction were explained to the investigator.
The investigator, or designated representative, should complete the case report form pages as soon as possible after information is collected, preferably on the same day that a study patient is seen for an examination, treatment, or any other study procedure. Any outstanding entries must be completed immediately after the final examination. An explanation should be given for all missing data.
A source data location list was prepared prior to study initiation. This list was filed in both the trial master file and the investigator study file and updated as necessary.
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
- Double (Investigator, 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 7~90 days old;
- •Fed by breast milk before enrollment;
- •Concent form signed by parents
排除标准
- •Twins, multiple births, 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 study results;
- •Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other diseases;
- •Having neonatal diarrhea or acute respiratory infections within 48 hours 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 within 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;
- •Have participated in other clinical studies within 3 months prior to the date of screening;
- •Unable to comply the study schedule
结局指标
主要结局
Bone density change from baseline (Tibial speed of sound measurement)
时间窗: After 12 weeks of study intervention
Week 12 values minus Baseline (week 0) values
次要结局
- Incidence of Eczema(Baseline (week 0), week 4, week 8, week 12)
- Growth measurements(Baseline (week 0), week 4, week 8, week 12)
- Fecal short-chain fatty acid concentration(Baseline (week 0), week 12)
- Intestinal adherence questionnaire(Daily up to 12 weeks)
- Adverse event(Daily up to 12 weeks)
- Stool consistency(Daily up to 12 weeks)
- Fecal bacteria count(Baseline (week 0), week 12)