跳至主要内容
临床试验/NCT02745977
NCT02745977已完成不适用

Breast Milk Protein Intolerance and Maternal Dairy Consumption

Winthrop University Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Presence of blood in the stool as evidenced by positive stool guaiac

研究概览

简要总结

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. Investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.

详细描述

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. The investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.Some infants have difficulty digesting breast milk. When this happens, the doctor may advise the mother to eliminate dairy from her diet as long as the mother continues breast feeding or until the baby is 12 months old. However, no studies have proven that this change in a mother's diet actually solves the baby's problem with breast milk. The purpose of this study is to find an answer to this question.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with exclusively breast fed infants less than 4 months of age
  • Infant that has a positive stool guaiac

排除标准

  • Formula fed infants

结局指标

主要结局

Presence of blood in the stool as evidenced by positive stool guaiac

时间窗: 3 weeks

If guaiac positive, then dairy is reintroduced to diet

guaiac negative on diary free diet

时间窗: 3 weeks

if guaiac negative on dairy free diet after 3 weeks, will rechallenge with dairy to prove that blood in stool is caused by dairy in mother's diet

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farrah Lazare, MD

Attending Physician, Pediatric Gastroenterology

Winthrop University Hospital

研究点 (2)

Loading locations...

相似试验

Recruiting All Strictly Breast-fed Babies With Blood... | 临床试验