跳至主要内容
临床试验/CTRI/2009/091/000346
CTRI/2009/091/000346已完成2 期

Effect of trace amounts of dietary gluten on nutritional, clinical, serological, biochemical and histological parameters of pediatric patients with celiac disease.

Indian Council of Medical Research ICMR New Delhi0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Screening I (Atleast one month before baseline):
  • The subjects recruited for the study were biopsy and serology-proven celiac disease patients who were 7 to 12 yrs of age (either sex), and compliant on gluten-free diet for atleast 1 year.
  • The confirmed CD patients who satisfy the following criteria were included:
  • a)7 to 12 yrs of age.
  • b)Either sex.
  • c)Confirmed CD patients on gluten-free diet for at least 1year - By following a standard GFD compliance protocol.
  • d)CD patients who gave consent and were able to follow-up for the microchallenge.
  • Screening II (At Baseline)
  • Those patients were recruited for microchallenge who were Anti-EMA negative, showed improvement in Histology (Marsh criteria) from:
  • Severe to either moderate or mild villus atrophy or normal
  • Moderate to mild villus atrophy or normal
  • Mild villus atrophy to normal

排除标准

  • The following patients were excluded:
  • a)Poorly compliant on GFD.
  • b)Those having other autoimmune diseases.

研究者

发起方
Indian Council of Medical Research ICMR New Delhi

相似试验