New method for detecting markers in children with celiac disease
Validation of a New Innovative Method for the Easy Detection of a Disease Specific Marker to Make Prompt Diagnosis of Celiac Disease in All the Clinical Manifestations: a Paediatric Multicenter Study.
This study is testing a new way to find early signs of celiac disease in children to help doctors diagnose it more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 332 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 4 sites (Naples and 3 other locations) |
| Trial ID | NCT06324539 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate an innovative method for detecting specific markers associated with celiac disease (CD) in children. It focuses on identifying intestinal CD-autoantibodies that may indicate potential CD before the appearance of serum antibodies. The study involves patients undergoing elective esophagogastroduodenoscopy for suspected CD and other gastrointestinal conditions. By utilizing a rapid intestinal anti-TG2 assay, the study seeks to improve diagnostic accuracy for patients with uncertain CD diagnoses.
Who should consider this trial
Good fit: Ideal candidates include children undergoing esophagogastroduodenoscopy for suspected celiac disease or related gastrointestinal disorders.
Not a fit: Patients who have already been diagnosed with celiac disease according to the latest ESPGHAN guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to earlier and more accurate diagnoses of celiac disease in children, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic methods for celiac disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected Celiac Disease (CD), eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease. Exclusion Criteria: * Bleeding disorders * Patients fulfilling the new European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines for diagnosing CD (version 2020) for a serology-based CD diagnosis * Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process
Where this trial is running
Naples and 3 other locations
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Recruiting)
- Consorzio per Valutazioni Biologiche e Faramacologiche — Pavia, Italy (Active_not_recruiting)
- Azienda ULSS2 Marca Trevigiana — Treviso, Italy (Recruiting)
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Alberto Tommasini, MD PhD Prof
- Email: alberto.tommasini@burlo.trieste.it
- Phone: +39.040.3785.422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.