Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change of total symptom score of infant feeding & stool pattern questionnaire.
研究概览
简要总结
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
详细描述
This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.
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
- None
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
- •Infant is between 30-180 days of age.
- •Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
排除标准
- •Complementary food was added for infants or parents are willing to add complementary food during study.
- •Suffer from infection/illness.
- •Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- •Infant has visible bloody stools (detected before enrollment) prior to enrollment.
- •Participation in another study.
研究组 & 干预措施
Normal Formula
Normal Formula
干预措施: Normal Formula (Other)
Partially Hydrolyzed Formula
Infant was identified and got 1 or more scores by using infant feeding & stool pattern questionnaire at Visit 1 will be assigned into experimental group randomly
干预措施: Partially Hydrolyzed Formula (Other)
结局指标
主要结局
Change of total symptom score of infant feeding & stool pattern questionnaire.
时间窗: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).
Investigator report questionnaire. Total score consists of 6 sub scores based on different symptom scaleing : diarrhea(0= no; 1= yes), constipation(0= no; 1= yes), galactorrhea/spit milk(0= no; 1= yes), Irritability or crying(0= no; 0.5= yes), bloating/ tummy drum/ exhaust(0= no; 1= yes), other(0= no, 0.5=yes).
次要结局
未报告次要终点