A no-biopsy method for diagnosing celiac disease using antibody tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to establish optimal thresholds for IgA anti-tissue transglutaminase (tTG-IgA) antibody assays to diagnose celiac disease without requiring an intestinal biopsy. It will evaluate the diagnostic performance of various commercially available assays and determine if a titer cut-off above 10 times the upper limit of normal is effective across all tests. The study will enroll both pediatric and adult patients with new-onset celiac disease during 2023 and 2024, collecting serum samples for analysis. The research seeks to improve diagnostic accuracy and patient experience by minimizing invasive procedures.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Patients, on gluten-containing diet, with TGt-IgA antibodies \> Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).
* Patients with TCRγδ+ \>10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.
* Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies \>10xULN) without duodenal biopsy performed.

Exclusion criteria:

* Patients already diagnosed with CD.
* Patients who refused duodenal biopsy.
* Patients with primary or secondary immunodeficiencies.
* Patients with malignancy.
* Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.

Where it's running

• Hospital Mutua Terrassa
  Terrassa, Barcelona, Spain Recruiting
• Hospital Universitario Lucus Augusti
  Lugo, Lugo, Spain Recruiting
• Hospital Universitario La Paz
  Madrid, Madrid, Spain Recruiting
• Hospital Sant Joan de Deu
  Barcelona, Spain Recruiting
• Hospital Ramon y Cajal
  Madrid, Spain Recruiting
• Hospital Universitario Fundación Jimenez Diaz
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Marta Molero-Luis, Dr — Hospital Universitario La Paz
• Study coordinator: Marta Molero-Luis, Dr
• Email: marta.molero@salud.madrid.org
• Phone: 0034660065755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mediterranean diet and processed food in adults with celiac disease on a gluten-free diet

  This observational study looks at whether following a Mediterranean-style diet or eating more highly processed foods affects GI symptoms and quality of life in adults with celiac disease who have been on a strict gluten-free diet.

  Recruiting at 7 sites Istituti Clinici Scientifici Maugeri SpA · Brescia, BS and 6 other locations · NCT07915063

• Exercise for Metabolic Syndrome and Fatty Liver in Adolescent Girls with Celiac Disease

  This study tests whether a 3-month walking program helps improve metabolic syndrome and fatty liver in adolescent females with celiac disease.

  Recruiting Cairo University · Giza, Dokki · NCT07832994

• Nutrition and physical activity education for children with celiac disease

  This study tests whether a combined nutrition and physical activity education program helps 8- to 12-year-olds with celiac disease improve body health, eating habits, activity, and quality of life while on a gluten-free diet.

  Recruiting Bahçeşehir University · Istanbul, Besiktas · NCT07750795

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Omega-3 fats to reduce inflammation in adults with newly diagnosed celiac disease

  This study tests whether adding omega-3 fatty acid supplements to a gluten-free plan helps reduce inflammation and promote intestinal healing in adults who have just been diagnosed with celiac disease.

  Recruiting University of Chile · Santiago, Metropolitan Region · NCT07585669

• Wheat sensitivity or IBS/functional dyspepsia in relatives of people with celiac disease

  This project will test whether adults related to celiac patients have higher rates of non-celiac wheat sensitivity or IBS/functional dyspepsia and whether symptoms change on a wheat-free diet.

  Recruiting at 2 sites University of Palermo · Palermo, PA and 1 other locations · NCT07584473

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.