Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-15

Study Completion Date

2024-03-15

Brief Summary

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Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).

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Detailed Description

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Conditions

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Coeliac Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected CD, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion Criteria

* Bleeding disorders
* Patients fulfilling the new ESPGHAN Guidelines for diagnosing CD (version 2020), for a serology based CD diagnosis
* Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.

Minimum Eligible Age

1 Year

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No