Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lessening in bloating
研究概览
简要总结
This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.
详细描述
Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.
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
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Aged 6-24 months
- •Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance
- •Patients on formula or mixed feeding, or formula/cow/buffalo milk
排除标准
- •Severe acute malnutrition
- •Hemodynamic instability (shock)
- •Those on oral antibiotics or on excessive juices
- •With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)
研究组 & 干预措施
Lactase enzyme group
In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding.
干预措施: Lactase enzyme (Dietary Supplement)
Lactose-free formula feed group
In this group, lactose-free formula milk/diet was advised.
干预措施: Lactose-free formula feed (Dietary Supplement)
结局指标
主要结局
Lessening in bloating
时间窗: 5 days
It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape
Resolution of nausea/vomiting no perianal rash or only
时间窗: 5 days
Decrease in the frequency of nausea/vomiting
Resolution of perianal rash
时间窗: 5 days
If no perianal rash or only erythema is seen
Resolution of diarrhea
时间窗: 5 days
It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5)
Reduction in abdominal pain
时间窗: 5 days
A score of ≤ 4, assessed on the basis of faces pain score revised chart (FPS-R), was considered as reduction in pain (a higher score indicating more severe pain)
次要结局
- Treatment successful(6 days)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research