Lactose Intolerance in Infants With Gastrointestinal Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.
研究概览
简要总结
This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Artificially fed infants.
- •Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.
- •Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.
排除标准
- •Infants with positive family history of Cow's milk protein allergy CMPA.
- •Any allergic diseases.
- •History of anaphylaxis.
- •Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest.
研究组 & 干预措施
Artificially fed infants
Infants who presented by GIT symptoms and their Cow's Milk-related Symptom Score (CoMiSS) ≥ 12 who received lactose free diet regimen for 2 weeks then received then a regimen containing lactose, a tailored dietary plan was given to each participant, and it included lactose-containing formula and dairy based products like yogurt and cheese were included for infants over 6 months.
干预措施: lactose free regimen (Other)
结局指标
主要结局
Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.
时间窗: 4 weeks intervention
Number of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA)
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University