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临床试验/NCT06497907
NCT06497907已完成不适用

Prevalence of Environmental Enteropathy Among Infants and Children With Growth Faltering

Ain Shams University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Assessment of the prevalence of environmental enteropathy among children with faltering growth.

研究概览

简要总结

The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients whose weight below -2 SD for age and sex on the WHO scores.

排除标准

  • Secondary cases of malnutrition or undernutrition.
  • Patients with symptoms of GIT problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum.
  • Patients who can't commit to a follow up visit every two weeks.

结局指标

主要结局

Assessment of the prevalence of environmental enteropathy among children with faltering growth.

时间窗: 12 weeks of nutritional rehabilitation with polymeric formula.

Assess the number of patients whose weight still below -2SD and upper gastrointestinal endoscopy showed the criteria of environmental enteropathy.

次要结局

  • Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula.(8 weeks of nutritional rehabilitation with peptide-based formula.)

研究者

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

Haya Essam Ibrahim

Lecturer of pediatrics

Ain Shams University

研究点 (2)

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