Prospective Celiac Disease Diagnosis Evaluation (ProCeDE).
- Conditions
- 10025477spruecoeliac disease
- Registration Number
- NL-OMON37411
- Lead Sponsor
- European Society of Peadiatric Gastroenterology, Hepatology and Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Consecutive children (age > 6 months - < 18.0 years) with a high degree suspicion for celiac disease consuming a gluten containing diet:
- A child with clinical symptoms indicative of celiac disease plus a positive test of any titer specific height for celiac disease specific antibodies (TG2, EMA, DGP- cave positive DGP-titer alone does not quanlify the patient for biopsy!) or
- A child with an increased risk for celiac disease such as having relatives of celiac disease patients or patients with diseases associated with celiac disease (Hashimoto Thyroiditis, Type I DM, Down's symdrome) with no or mild unspecific clinical symptoms but with a positive test for celiac disease specific antibodies (positive test for TG2 and/or positive EMA (>1:10)).
- Patient with symptoms that may indicate celiac disease, but negative celiac disease specific antibodies (TG2 or EMA), but normal IgA.
- Patient without symptoms, and negative celiac specific antibodies (TG2 and EMA)
- Malignancy
- Serious chronic infections such as HIV or tuberculosis or congenital immunodeficiency
- Contraindications for endoscopy/biopsies
- Parents did not sign consent form
- Parents can not read/are not able to understand to give informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate whether the omission of biopsies in selected pediatric cases does<br /><br>result in certain diagnosis of celiac disease (avoid false positive diagnosis<br /><br>of celiac disease).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate characteristics and severity of symptoms in relation to histology<br /><br>and celiac disease specific antibody titers.<br /><br>- To determine the best optimal cut-off point for antibody levels in children<br /><br>with symptoms of celiac disease which predict mucosal damge with 99%<br /><br>specificity.<br /><br>- To determine whether the determination of HLA typing adds diagnostic value in<br /><br>cases with positive specific antibodies.<br /><br>- To determine which of the available antibody tests (TG2, EMA, DGP) are most<br /><br>suitable for the initial diagnosis in relation to age and type of symptoms.</p><br>