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NCT03320811 Clinical Trial

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

Celiac Disease Clinical Trial

— DGP-CeliacDis  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03320811
Other study ID # 2016Ao005
Secondary ID
Status Completed
Phase N/A
First received October 23, 2017
Last updated October 23, 2017
Start date January 1, 2015
Est. completion date January 1, 2016

Study information
Verified date October 2017
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 2026
Est. completion date January 1, 2016
Est. primary completion date September 1, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Data record

Locations
Country Name City State
France Damien JOLLY Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary celiac disease The celiac disease diagnosis was based on the histological lesions at duodenal biopsies (villous atrophy). Biopsy samples were obtained during upper gastrointestinal tract endoscopy. Day 0
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