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临床试验/NCT07157137
NCT07157137尚未招募不适用

Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease

Medical University of Warsaw0 个研究点目标入组 140 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
主要终点
Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.

研究概览

简要总结

Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested.

This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status.

Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.

时间窗: January 2026 - June 2027

Adherence to the gluten-free diet will be assessed based on positive results in the Celiac Dietary Adherence Test questionnaire.

Adherence to the gluten-free diet - the gluten immunogenic peptide in urine.

时间窗: January 2026 - June 2027

Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in urine (uGIP).

Adherence to the gluten-free diet - the gluten immunogenic peptide in stool.

时间窗: January 2026 - June 2027

Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in stool (sGIP).

Comparison of methods

时间窗: January 2026 - June 2027

The results of CDAT questionnaire, uGIP and sGIP will be compared to the standard IgA tissue transglutaminase antibody test. Intra-assay agreement will be assessed using the McNemary test. Measures of test quality (sensitivity, specificity, positive and negative predictive values) will be calculated.

次要结局

  • The nutritional status of Polish children with coeliac disease(January 2026 - June 2027)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Banaszkiewicz

MD, PhD, Prof.

Medical University of Warsaw

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