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Search / Trial NCT06206616

Liver Steatosis in Pediatric CD Patients

Launched by UNIVERSITY OF PALERMO · Jan 4, 2024

Trial Information

Current as of July 28, 2025

Not yet recruiting

Keywords

Celiac Disease Non Alcoholic Fatty Liver Disease Intestinal Permeability Inflammatory Cytokines Children

ClinConnect Summary

This clinical trial is investigating the relationship between Celiac Disease (CD) and Non-Alcoholic Fatty Liver Disease (NAFLD) in children. Celiac Disease is a condition that affects the digestive system when gluten, a protein found in wheat, is consumed. Some children with CD may also develop NAFLD, a condition where fat builds up in the liver without alcohol being involved. The study aims to find out how common NAFLD is among children with CD and whether following a gluten-free diet (GFD) can help improve liver health. Researchers also want to understand if changes in the gut (the digestive tract) contribute to the development of NAFLD in these children.

To participate in the study, children need to be between 1 and 14 years old and have a confirmed diagnosis of Celiac Disease. Unfortunately, children with certain health issues, like severe liver problems or chronic infections, won't be eligible to join. Those who qualify will be monitored to see how their liver health responds to changes in their diet and gut health. This study is important because it could help improve our understanding of how Celiac Disease affects children's overall health, especially regarding their liver function.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age \>1 and \<14 years
  • Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria
  • Exclusion Criteria:
  • age \<1 and \>14 years;
  • self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
  • bacterial and/or parasitic infections;
  • diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, immunological deficits and impairments that limit physical activity;
  • diagnosis of cancer
  • patients undergoing chemotherapy and/or radiotherapy.

About University Of Palermo

The University of Palermo, a distinguished institution located in Italy, is dedicated to advancing medical research and education through innovative clinical trials. Renowned for its commitment to scientific excellence, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct research that addresses critical healthcare challenges. By fostering collaborations with leading researchers and healthcare professionals, the University of Palermo aims to translate scientific findings into effective therapies, ultimately contributing to improved patient outcomes and public health advancements.

Locations

Palermo, , Italy

Palermo, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported