Anti-Tissue Transglutaminase IgA Antibodies

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04019223
Collaborator
(none)
22
17

Study Details

Study Description

Brief Summary

Celiac disease is the most common genetically related food intolerance, worldwide. It is an immune mediated intolerance to gluten (from wheat, barley, or rye) in genetically susceptible individuals .The disease primarily affects the small intestine, where it progressively leads to flattening of the small intestinal mucosa .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: anti-tissue transglutaminase group
  • Diagnostic Test: biopsy group

Detailed Description

Within this definition, patients can further be defined as having silent, potential, or latent celiac disease. The term silent celiac disease refers to patients fulfilling the definition above, but presenting no symptoms. Typically, such diagnoses are made by screening asymptomatic individuals, who are at increased risk for celiac disease. The term potential celiac disease describes patients who have specific serum autoantibodies and may or may not have symptoms consistent with celiac disease, but lack evidence of the autoimmune damage to the intestinal mucosa. A final category of celiac patients is represented by the so-called latent celiac disease: individuals with normal mucosal morphology (like the potential) but known to have had a gluten-dependent enteropathy at some point in their life .

Malabsorption results from injury to the small intestine with loss of absorptive surface area, reduction of digestive enzymes, and consequential impaired absorption of micronutrients such as fat-soluble vitamins, iron and potentially B12 and folic acid. In addition, the inflammation exacerbates symptoms of malabsorption by causing net secretion of fluid that can result in diarrhea. The failure of absorption of adequate calories leads to weight loss, and the malabsorption results in abdominal pain and bloating .

A positive family history is a risk factor for celiac disease. The frequency of celiac disease is higher among first- and second-degree relatives of persons with celiac disease, although prevalence estimates range from 5 to 20 percent . Frequency of celiac disease is also higher among persons with other autoimmune diseases, such as type 1 diabetes mellitus, inflammatory luminal gastrointestinal disorders, Down syndrome, Turner's syndrome, IgA deficiency, and IgA nephropathy .

Gastrointestinal and extra-intestinal manifestations of celiac disease include diarrhea, abdominal pain, abdominal distention, anorexia, vomiting, constipation, failure to thrive, chronic fatigue, anemia, osteoporosis, aphthous stomatitis, elevated liver enzymes, joint/muscle pain, epilepsy, and peripheral neuropathy .

Clinical practice guidelines recommend to starting with the serum anti-tissue transglutaminase IgA antibodies (anti-tTG IgA) test as a diagnostic testing for celiac disease. The tTG IgA test is the standard method of testing for celiac disease . Clinical practice in guidelines the United States and Europe recommend intestinal biopsy to confirm the diagnosis of celiac disease (e.g., based on presence of villous atrophy hyperplasia of crypts, and increase of intraepithelial lymphocytes) and to distinguish celiac disease from other disorders affecting the small intestine. Intestinal biopsy may also be performed if clinical suspicion for celiac disease is high but serologic tests are negative . It has been suggested that a combination of serologic tests could be used to establish celiac disease diagnosis as an alternative to biopsy, but it is unclear how frequently celiac disease is diagnosed in the absence of biopsy in clinical practice.

Study Design

Study Type:
Observational
Anticipated Enrollment :
22 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Diagnostic Performance of Anti-Tissue Transglutaminase IgA Antibodies Serum Level for Detection of Patients With Celiac Disease
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Sep 30, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
anti-tissue transglutaminase group

serum IgA-tissue transglutaminase antibody (tTG) was analyzed in serum using a quantitative automated ELISA method by means of a commercially available detection kit using recombinant human tTG as antigen recommended cut-off by the manufacturer > 8 U/mL).

Diagnostic Test: anti-tissue transglutaminase group
Determination of anti-tissue transglutaminase IgA antibodies serum level.

Diagnostic Test: biopsy group
Intestinal biopsy for histopathology study the jejunal histopathological

biopsy group

upper gastrointestinal endoscopic examination will be done and the jejunal histopathological examinations will be done at the Histopathology Laboratory. The features consistent with CD included: hyperplasia of crypts, atrophy of villous, and increase of intraepithelial lymphocytes.Duodenal samples will be processed using haematoxylin/eosin staining and CD3 immunophenotyping. The number of intra-epithelial lymphocytes (IEL), the architecture of villi, and the inflammatory cell infiltration of the lamina propria will be assessed. Histopathological changes will be classified according to the Marsh-Oberhuber criteria.Lymphocytic enteropathy (Marsh 1 lesion) was defined as 25 or more IEL per 100 epithelial nuclei, and normal villous architecture.

Diagnostic Test: anti-tissue transglutaminase group
Determination of anti-tissue transglutaminase IgA antibodies serum level.

Diagnostic Test: biopsy group
Intestinal biopsy for histopathology study the jejunal histopathological

Outcome Measures

Primary Outcome Measures

  1. measure of Anti- tissue will be performed to calculate the post-test probability of celiac disease. [within 24 hours]

    tTG are regarded as qualitative, i.e., positive or negative.Values of tTG between 2 and 7 U/mL will be considered as doubtful positive, and those of 7 U/mL or more as positive. cut-off of ≥7 U/mL will be used in this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • patients with symptoms suggestive of celiac disease
Exclusion Criteria:

•chronic active gastrointestinal disease, i.e., irritable bowel syndrome inflammatory bowel disease .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Suzan Alaa Babran, principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04019223
Other Study ID Numbers:
  • DPAAB
First Posted:
Jul 15, 2019
Last Update Posted:
Jul 15, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2019