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

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ClinicalTrials.gov Identifier: NCT03320811
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Celiac Disease Other: Data record

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

Study Type : Observational
Actual Enrollment : 2026 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : January 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Group/Cohort Intervention/treatment
group "celiac disease" Other: Data record
group "no celiac disease" Other: Data record



Primary Outcome Measures :
  1. celiac disease [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320811


Locations
France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03320811     History of Changes
Other Study ID Numbers: 2016Ao005
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Celiac disease
serological tests
anti-deamidated gliadin peptide antibodies

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs