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Completed

NCT Number: NCT03663309

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

detecting Gluten peptides in faecal and urine samples

Diagnostic Test

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

Primary outcomes

  1. Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.

    Time frame: one year

    Our goal is to examine which method will be the most accurate, nutritional assessment or laboratory tests for the adherence to GFD

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2018
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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