A prospective multicenter study for the evaluation of a Point-of-Care Test (POCT) for the diagnosis of celiac disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012499

Enrollment

1000

Registered

2017-07-14

Start date

2016-01-09

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

K90.0

Interventions

Group 1: Finger prick blood of patients registered for gastroscopy and eligible for the study will be analyzed by the POCT for celiac disease diagnosis (IgA and IgG for deamidated gliadin peptides

Simtomax™ test, Tillots, Switzerland). Test results will be compared with duodenal histology (Marsh classification).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient referred for gastroscopy for one of the following reasons: dyspepsia, abdominal pain, unexplained anemia, weight loss, diarrhea, gastroesophageal reflux symptoms, dysphagia, suspected gastrointestinal bleeding

Exclusion criteria

Exclusion criteria: Coagulopaty, known diagnosis of celiac disease and ongoing gluten-free diet.

Design outcomes

Primary

Measure	Time frame
Sensitivity, Specificity	—

Secondary

Measure	Time frame
Celiac disease Prevalence	—

Countries

Germany

Contacts

Public ContactPaul Tangermann

Charité Campus Benjamin Franklin

paul.tangermann@charite.de+491723667584

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 5, 2026