Celiac Disease in ChildrenNCT06324539
Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease
An observational study of Celiac Disease in Children, run by IRCCS Burlo Garofolo at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Diagnostic Test: Rapid Intestinal anti-TG2 Assay
- How many people
- 332 participants
- Where
- 4 sitesItaly
- Study dates
- 4 Oct 2023to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children (aged between 2 and 17 years) referred to the Gastroenterology Units for elective gastro-intestinal endoscopy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
Renata Auricchio, MD, r.auricchio@unina.it
- Active, not recruiting
Consorzio per Valutazioni Biologiche e Faramacologiche
Pavia
- Recruiting
Azienda ULSS2 Marca Trevigiana
Treviso
Stefano Martelossi, MD, stefano.martelossi@aulss2.veneto.it
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Luigina De Leo, +39.040.3785.472, luigina.deleo@burlo.trieste.it
About this study
Official title: 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.
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.
Read more
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).
- Conditions
- Celiac Disease in Children
- Being tested
- Diagnostic Test: Rapid Intestinal anti-TG2 Assay
- Keywords
- Celiac disease, Intestinal antibodies, Rapid test
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Rapid Intestinal anti-TG2 AssayDiagnostic test
Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging.
Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis.
Diagnostic Test: Rapid Intestinal anti-TG2 AssayDiagnostic test
Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging.
Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease subjects | Not described Receives: Diagnostic Test: Diagnostic Test: Rapid Intestinal anti-TG2 Assay | |
| Controls subjects | Not described Receives: Diagnostic Test: Diagnostic Test: Rapid Intestinal anti-TG2 Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Measured: Through study completion, an average of 18 months
Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Measured: Through study completion, an average of 18 months
Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Measured: Through study completion, an average of 18 months
Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start4 Oct 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324539
- Sponsor's protocol ID
- PNRR-POC-2022-12376280
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06324539
- Acronym / sponsor ID
- PNRR-POC-2022-12376280
- Conditions
- Celiac Disease in Children
- Keywords
- Celiac disease, Intestinal antibodies, Rapid test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease subjects | – | Diagnostic Test: Diagnostic Test: Rapid Intestinal anti-TG2 Assay |
| Controls subjects | – | Diagnostic Test: Diagnostic Test: Rapid Intestinal anti-TG2 Assay |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children (aged between 2 and 17 years) referred to the Gastroenterology Units for elective gastro-intestinal endoscopy.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Rapid Intestinal anti-TG2 AssayEvaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging. Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis. | Diagnostic test | Celiac Disease subjects |
| Diagnostic Test: Rapid Intestinal anti-TG2 AssayEvaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging. Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis. | Diagnostic test | Controls subjects |
Primary outcome
Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Time frame: Through study completion, an average of 18 months
Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis
Time frame: Through study completion, an average of 18 months
Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Time frame: Through study completion, an average of 18 months
Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis
Time frame: Through study completion, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children, run by IRCCS Burlo Garofolo at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Tommasini, MD PhD Prof (+39.040.3785.422, alberto.tommasini@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis (time frame: Through study completion, an average of 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.