Skip to content

ProCeDE - Prospective Celiac Disease Diagnostic Evaluation

ProCeDE - Prospective Celiac Disease Diagnostic Evaluation - ProCeDE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00003555
Enrollment
750
Registered
2012-02-29
Start date
2011-11-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K90.0

Interventions

Group 1: Children with high suspicion of Celiac Disease due to elevated blood markers (CD specific autoantibodies) who will be reanalyzed for these blood markers and will undergo small bowel biopsy.

Sponsors

Klinikum der Ludwig-Maximilians-Universität Dr. von Haunersches Kinderspital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 17 Years

Inclusion criteria

Inclusion criteria: Consecutive children (age > 6 months - 1:10).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Iran, Israel, Italy, Netherlands, Poland, Portugal, Romania, Russia, Slovenia, Spain, United Kingdom

Contacts

Public ContactKatharina Werkstetter

Klinikum der Ludwig-Maximilians-Universität Dr. von Haunersches Kinderspital

katharina.werkstetter@med.uni-muenchen.de+49-89-44005-3680

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 9, 2026