- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805816
Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease
Study Overview
Status
Conditions
Detailed 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Petach-Tikva, Israel
- Schneider Children's Medical Center of Israel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Study group: 100 children with suspicion of CD based on positive serology (TG2 >2 times upper limit of normal) and classical clinical manifestations or belonging to high risk groups, who underwent gastroscopy with intestinal biopsies.
Control group: 100 children without suspicion of CD who underwent gastroscopy for other reasons (abdominal pain, failure to thrive, vomiting, eg)
Description
Inclusion Criteria:
- Child with clinical suspicion of CD (chronic or recurrent diarrhea, Failure to thrive, growth impairment , iron deficiency anemia, vomiting, chronic abdominal pain, abdominal distension , constipation, fatigue, recurrent oral aphthous or dermatitis herpetiformis) and high TG2 serology (>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies Or
Asymptomatic child who belongs to high risk group of celiac (Diabetes mellitus type 1, Hashimoto thyroiditis, Down syndrome, Turner syndrome, Williams syndrome, Auto-immune Hepatitis or first degree with CD) and high TG2 serology (>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies .
and
- signed consent form
Exclusion Criteria:
- IgA (Immunoglobulin A) deficiency
- Malignancy
- Inflammatory Bowel Disease
- Severe chronic infection (HIV, Tuberculosis)
- Primary immunodeficiency
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study group
Children with suspicion of CD based on positive serology (TG2 >2 times upper limit of normal) and classical clinical manifestations or belonging to high risk groups, who underwent gastroscopy with intestinal biopsies.
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Control group
Children without suspicion of CD who underwent gastroscopy and duodenal biopsies for other reasons (abdominal pain, failure to thrive, vomiting, eg)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Diagnosis of Celiac Disease based on histological findings.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Firas Rinawi, MD, Schneider Children's Medical Center, Israel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0466-15 RMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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