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.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut. However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain. CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy). The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays. In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
Consorzio per Valutazioni Biologiche e Faramacologiche
ACTIVE_NOT_RECRUITING
Pavia
Azienda ULSS2 Marca Trevigiana
RECRUITING
Treviso
Institute for Maternal and Child Health - IRCCS Burlo Garofolo
RECRUITING
Trieste
Contact Information
Primary
Alberto Tommasini, MD PhD Prof
alberto.tommasini@burlo.trieste.it
+39.040.3785.422
Backup
Lugina De Leo
luigina.deleo@burlo.trieste.it
+39.040.3785.472
Time Frame
Start Date: 2023-10-04
Estimated Completion Date: 2025-05
Participants
Target number of participants: 332
Treatments
Celiac Disease subjects
Controls subjects
Related Therapeutic Areas
Sponsors
Leads: IRCCS Burlo Garofolo

This content was sourced from clinicaltrials.gov