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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03663309
Enrollment
194
Registered
2018-09-10
Start date
2018-06-19
Completion date
2021-06-03
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease in Children

Brief 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 .

Interventions

DIAGNOSTIC_TESTdetecting 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

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years

Inclusion criteria

* Age 2-17 years. * Either diagnosis of celiac disease or, in controls, no systemic disease or inflammation * For all groups parents will provide informed consent.

Exclusion criteria

° Children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.one yearOur goal is to examine which method will be the most accurate, nutritional assessment or laboratory tests for the adherence to GFD

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026