Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

Completed

• Conditions: Celiac Disease
• Interventions: Other: Data record

• Registration Number: NCT03320811
• Lead Sponsor: CHU de Reims

Brief Summary

Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

Detailed Description

The aim was to assess the clinical relevance of anti-deamidated gliadin peptide antibodies compared with the other common celiac markers.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-09-01
• Study Completion: 2016-01-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2026

Inclusion Criteria

• patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed between 1 april 2012 to 31 december 2014

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group "celiac disease"	Data record	-
group "no celiac disease"	Data record	-

Primary Outcome Measures

Name	Time	Method
celiac disease	Day 0	The celiac disease diagnosis was based on the histological lesions at duodenal biopsies (villous atrophy). Biopsy samples were obtained during upper gastrointestinal tract endoscopy.

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France