Urinary Gluten Immunogenic Peptide as a biomarker for monitoring adherence to diet in children with Celiac disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the urinary GIP levels from baseline after institution of gluten free diet
研究概览
简要总结
This is short term longitudinal study to evaluate use of urinary Gluten Immunogenic Peptide as a biomarker for monitoring adherence to gluten free diet in children with celiac disease conducted in department of pediatrics, Maulana Azad Medical college and Lok Nayak hospital.
Children newly diagnosed with Celiac disease between 1-12 years age, presenting to the Department of Pediatrics will be enrolled and change in levels of Urinary Gluten Immunogenic Peptide at 7 days and at 1 month of initiation of Gluten-Free Diet will be analysed. The association of Urinary GIP levels and anti tTG-IgA levels at baseline and after 1 month of GFD will also be assessed. The proposed sample size is of 30 patients. The aim is to evaluate if urinary Gluten immunogenic peptide levels can assess compliance to Gluten free diet.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children newly diagnosed with Celiac disease between 1-12 years age, presenting to the Department of Pediatrics.
- •Diagnosis of CD will be made as per ESPGHAN 2020 criteria.
排除标准
- •1.Patients with known chronic inflammatory bowel disease 2.Patients with a history of necrotizing enterocolitis and known short bowel syndrome 3.Patients with known chronic kidney disease.
结局指标
主要结局
Change in the urinary GIP levels from baseline after institution of gluten free diet
时间窗: At 1 week and at 1 month of starting gluten free diet
次要结局
- Association between Urinary GIP levels and anti tTG-IgA levels after 1 month of gluten free diet(At 1 month of gluten free diet)
研究者
Dr Shreya Gupta
Maulana Azad Medical College