NCT03663309

Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.

Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten Immunogenic Peptides in Faecal Samples and Nutritional Assessment. Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: —

Summary

To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.

Detailed description

The adherence to the GFD can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or CD serological screening tests showing decreasing levels of antibodies. However, none of these methods offer an accurate measure of dietary compliance. A novel method to monitor the adherence to the GFD by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin G12 antibody was described recently in the literature. Gluten peptides, in particular peptides equivalent to the immunogenic - α -gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces. Consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

Conditions

• Celiac Disease in Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	detecting Gluten peptides in faecal and urine samples	At each visit patient will: * Bring 4-day food diary (attached) * Fill symptoms and complaints questionnaire (attached) * Provide 24 h diet recall in case a food diary absents * Fill Biagi score questionnaire (attached) * Perform blood test of TTG * Provide stool and urine samples

Timeline

• Start date: 2018-06-19
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2018-09-10
• Last updated: 2021-10-01

Locations

1 site across 1 country: Israel