Clinical Trials Logo

Clinical Trial Summary

The investigators will perform prospective observational multicenter study which includes children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study group) and children without suspicion of CD who underwent gastroscopy for other reasons. The investigators will compare sensitivity, specificity and predictive values of several serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD according to histological findings.


Clinical Trial Description

Small bowel biopsies have so far been considered as the reference standard for the diagnosis of Celiac disease (CD). However, during the last decades evidence has accumulated on the diagnostic value of specific CD antibodies and has increasingly been used for diagnostic purposes. At the same time, the leading role of histology for the diagnosis of CD has been questioned for several reasons: histological findings are not specific for CD, lesions may be patchy and can occur in the duodenal bulb only and interpretation depends on preparation of the tissue and is prone to a high inter-observer variability. The diagnosis of CD may then depend not only on the results of small bowel biopsies, but also on information from clinical data and on results from specific CD antibody testing. ESPGHAN (European Society of Gastroenterology, Hepatology and Nutrition) guidelines for the diagnosis of CD which was recently published enabled diagnosis of CD based on classical symptoms and high titre levels (>10 times upper limit of normal) of tissue transglutaminase (TG2) and positive Endomysial Anti bodies (EMA) in separate blood samples.

Due to these facts, it is important to use serological kit for TG2 with high specificity and sensitivity. The aim of this study is to assess in a prospective study the kit with the highest sensitivity and specificity among patients with suspected CD.

The investigators will perform prospective observational multicenter study which includes children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study group) and children without suspicion of CD who underwent gastroscopy for other reasons. The investigators will compare sensitivity, specificity and predictive values of several serological kits of TG2 (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD according to histological findings. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02805816
Study type Observational
Source Rabin Medical Center
Contact
Status Completed
Phase
Start date June 8, 2016
Completion date July 2018

See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT05810441 - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Active, not recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2