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Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

NCT02242123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-10-08

No results posted yet for this study

Summary

Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically predisposed populations. Patients affected by the disease may be asymptomatic or manifest classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss after gluten ingestion (and related derivatives found in other grains). Diagnosis and screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG) and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in identifying susceptible individuals. CD diagnosis is still anchored to the criteria established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition in 1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia and increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten, and (b) a full clinical remission after elimination of gluten from the diet. As a consequence, patients with minimal or no intestinal histology lesions pose a considerable problem, as serum anti-tTG and EmA are known to be often negative, or weakly positive, in patients with CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG antibody in the culture medium of intestinal biopsy specimens from patients with suspected CD and evaluated the relationship between antibody production and severity of intestinal mucosal damage, and demonstrated that anti-tTG assay of the culture medium of biopsy specimens can improve the accuracy of CD diagnosis in patients negative for serum antibodies. The same investigators, in 2011, evaluated the diagnostic accuracy of EmA assay in the culture medium of intestinal biopsies for CD diagnosis and demonstrated that EmA assay in the culture medium had a higher sensitivity and specificity than serum EmA and anti-tTG assay. The present study is performed to investigate the clinical usefulness of the in vitro production of EmA in CD diagnosis in a large number of consecutive adult patients with suspected CD and weakly positive \[e.g. 2-3xN\] serum anti-tTG.

Conditions

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Carroccio, MD, PhD · Internal Medicine Department of the Hospital of Sciacca (Agrigento)

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-12-31
Completion
2020-06-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02242123 on ClinicalTrials.gov