Improved laboratory diagnostics for celiac disease.

Improved laboratory diagnostics for celiac disease. - Celiac Disease Diagnostics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54772

Enrollment

Registered

2019-04-25

Start date

2020-01-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

celiac disease gluten intolerance

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >= 18 years old - Indication for a duodenal biopsy for the diagnosis or monitoring of: active celiac disease, celiac disease on gluten free diet, suspicion celiac disease, dyspeptia, potential celiac disease OR previously diagnosed with celiac disease, dyspepsia or NCGS without an indication for duodenum biopsy - Given informed consent - HLA-DQ2.5 positive (in exceptional cases where endoscopic examination is already performed before HLA typing and the patient turns out to be HLA-DQ2.5 negative, the γδT-cell data can be used for analysis.

Exclusion criteria

Exclusion criteria: - No informed consent - Insufficient knowledge of Dutch language and/or inability to understand the information provided. - Systemic immune suppressive treatment for the past 3 months, - pregnancy (not applicable to groups 2b and 4b) - HIV, Hepatitis B or C positive status - Severe disorders within the last 6 months, e.g. cancer

Design outcomes

Primary

Measure	Time frame
1) Detection method for gliadin specific T-cells in peripheral blood 2) Determine celiac disease associated duodenal γδT-cell phenotype 3) Detection of γδT-cells with CD-related phenotype in peripheral blood 4) Sensitivity and specificity of cellular blood test (gliadin specific T-cells and γδT-cells with CD-related phenotype) for diagnosis of CD in patients on a gluten containing or GFD in a routine specialized diagnostic setting. 5) Sensitivity and specificity of cellular blood test (gliadin specific T-cells and γδT-cells with CD-related phenotype) for diagnosis of CD in CD patients that take a personalised glutenchallenge in a routine specialized diagnostic setting.	—

Measure

Time frame

1) Detection method for gliadin specific T-cells in peripheral blood 2) Determine celiac disease associated duodenal γδT-cell phenotype 3) Detection of γδT-cells with *CD-related phenotype* in peripheral blood 4) Sensitivity and specificity of cellular blood test (gliadin specific T-cells and γδT-cells with *CD-related phenotype) for diagnosis of CD in patients on a gluten containing or GFD in a routine specialized diagnostic setting. 5) Sensitivity and specificity of cellular blood test (gliadin specific T-cells and γδT-cells with *CD-related phenotype) for diagnosis of CD in CD patients that take a personalised glutenchallenge in a routine specialized diagnostic setting.

—

Countries

Netherlands

Outcome results