ProCeDE - Prospective Celiac Disease Diagnostic Evaluatio

• Conditions: K90.0; Coeliac disease

• Registration Number: DRKS00003555
• Lead Sponsor: Klinikum der Ludwig-Maximilians-UniversitätDr. von Haunersches Kinderspital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-29
• Study Completion: 2015-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 803

Inclusion Criteria

Consecutive children (age > 6 months - < 18.0 years) with a high degree suspicion for CD at a given center consuming a gluten containing diet and fullfilling one ore more of the following criteria:

• A child with clinical symptoms (e.g. chronic or intermittent diarrhoea, weight loss, failure to thrive, abdominal pain, iron-deficiency anemia, etc.) indicative of CD plus a positive test of any titer height for CD specific antibodies (TG2 and/or EMA) or

• A child with a increased risk for CD such as having relatives of CD patients or patients with diseases associated with CD (Hashimoto Thyroiditis, Type 1 DM, Down’s syndrome, etc.) with no or mild unspecific clinical symptoms but with a positive test for TG2 and/or a positive EMA test (>1:10).

Exclusion Criteria

• patient with symptoms that may indicate CD, but negative specific antibodies (TG2 or EMA), but normal IgA
• patient without symptoms, and negative Anti-TG2 and negative 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In patients with highly increased Anti-TG2-levels (about 7-10fold upper normal limit) plus symptoms and/or high risk for CD: accordance of CD diagnosis based on the new guidelines of the ESPGHAN and results of histological examinations respectively discordance between CD diagnosis based on new guidelines and histology. <br><br>

Secondary Outcome Measures

Name	Time	Method
not applicable