Scrutiny Based in a Novel Test to Help the Early Detection of Celiac Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Presence of Gluten Immunogenic Peptide (GIP) in urine
研究概览
简要总结
The use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and immunoglobulin A (IgA) anti tissue transglutaminase (anti-tTG) antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
This observational, cross-sectional study with no interventions applied in subjects consists on a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
The main outcome is to determine the prevalence of CD through mass screening within the pediatric and adolescent population in order to provide an early diagnosis and avoid long-term consequences which are suffered by untreated patients. As an international innovation, misdiagnosis (false negatives) because of an insufficient gluten intake are expected to be detected, thus the use of GIP detection in urine will confirm gluten ingestion at the diagnosis. Volunteers with a confirmed diagnosis of CD could be monitored by their doctors to corroborate whether a gluten-free diet improves their quality of life.
详细描述
Hypothesis: the use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and IgA anti-tTG antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.
Objectives:
Primary objective: to perform a mass screening in the pediatric and adolescent population (2 - 18 years old) in order to assess the prevalence of the CD providing early diagnosis of possible patients through 1 - Detection of IgA anti-tTG antibodies present in blood (to be measured by home rapid tests); 2 - Detection of GIP in urine (to be measured in situ or at a central laboratory).
Specific objectives: 1- To determine the prevalence of CD, particularly in children between 2 and 18 years old; 2 - To detect possible hidden CD cases, avoiding future irreversible damages by a late detection of this pathology such as growth impairment, decalcification, neurotoxicity or risks of suffering other autoimmune diseases; 3 - To detect misdiagnosis (false negatives) because of an insufficient gluten intake, as an international innovation.
Study design: this observational, cross-sectional study with no interventions applied in subjects consists of a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire, a short clinical questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Children and adolescents volunteers (2-18 years old).
- •Regular gluten consumption.
- •Willingness to perform the study and ability to collect urine samples.
- •The signing of the informed consent by the volunteer and his/her legal guardians.
排除标准
- •Related diseases or psychiatric alterations which do not recommend being included in the study as the researcher's consideration.
- •Lack of foreseeable collaboration.
- •Patients which do not provide samples or surveys in 70% of cases.
结局指标
主要结局
Presence of Gluten Immunogenic Peptide (GIP) in urine
时间窗: Only the testing day.
The immunochromatographic test iVYCHECK GIP Urine allows the detection of GIP resulting from gastrointestinal degradation of ingested gluten in urine. The detection step is based on the reaction of the 33-mer-like immunogenic peptides of gluten present in the sample with the coloured conjugated (monoclonal anti-gliadin 33-mer antibody/red-coloured microsphere) previously loaded in the cassette. Complexes spread through the cassette by capillarity and interact with a second anti-gliadin 33-mer antibody immobilized on the membrane at the test zone. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
Presence of IgA anti-tTG in blood
时间窗: Only the testing day.
The immunochromatographic test CeliacDetect allows the detection of IgA anti-tTG in blood samples. The detection step is based on the union of the IgA anti-tTG with anti human IgA antibodies labeled with colloidal gold and tTG (whose origin is the erythrocyte lysis in the dilution buffer). The complex would be bounded to the stable protein line (test line) by tTG. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
次要结局
- Presence of previous symptoms(Only the testing day.)