Derivation and Validation of a classification system for defining Response and Remission to Gluten-free diet in patients with Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease Activity Index
研究概览
简要总结
We are developing a Disease Activity Index and a classification system for defining Response and Remission to Gluten-free diet in patients with Celiac Disease.
A classification system for assessing the response to Gluten-free diet which is the only available treatment to Celiac Disease does not exist. The definition of remission is unclear, whether to look at clinical remission, serological remission or histological remission or a combination of all three; how much improvement in the patient can be called remission, how much improvement can we expect in the patient and after how much time of beginning of gluten-free diet should we expect remission. All these questions require consensus from experts in the field of celiac disease and should come through a systematic study. The monitoring and follow-up protocol of patients with Celiac Disease is not uniform globally and there are variations in the monitoring practices and therefore there is a need to standardise them as well.
Purpose“The enemy of medical progress is hypothetical or speculative reasoning of physicians”. With the development of a classification system, the response of patient to gluten-free diet will be assessed using a standard, objective tool that forms its basis on the subjective reasoning of the physicians. This will lead to improvement in patient-care, by looking at the grey area, between Non-responsive Celiac Disease and Responsive Celiac Disease, and help to provide personalised care. The score will also provide a universal approach to assess response and remission in patients with Celiac Disease but also at the same time being precise enough for an individual patient. A classification system will also be useful after drug discovery during clinical trials to define response and remission and a measure of Disease Activity. The study will be one of the initial steps to form the basis of monitoring practices owing to its regular follow-up method and assessment of dynamics of recovery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
入选标准
- •Patients with Celiac disease on a Gluten-free Diet
- •Patients with celiac disease as defined by positive Celiac Serology and proven by small intestinal mucosal biopsy: Diagnosis of CeD to be based on the combination of clinical manifestations, positive IgA anti-tTG antibody, and a deep duodenal biopsy demonstrating the presence of villous abnormalities of at least Marsh grade 2 (ICMR Guideline on Diagnosis and Management of Celiac Disease) [10]
- •Age: 18 to 60 years
- •Gender: Both male and female patients with CeD.
排除标准
- •Patients not willing to participate in the study
- •Patients with chronic illness (Cancer/Chronic Kidney Disease)
- •Pregnant or lactating mothers.
结局指标
主要结局
Disease Activity Index
时间窗: Baseline, 3 months, 6 months, 12 months
次要结局
- Response to Gluten-free diet score(6 months 1 year)
研究者
Govind K Makharia
All India Institute of Medical Sciences, New Delhi
