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

Celiac Disease in Children Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663309
• Other study ID #: 0367-17RMC
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: June 3, 2021

Study information

• Verified date: September 2021
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Intervention

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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.	Our goal is to examine which method will be the most accurate, nutritional assessment or laboratory tests for the adherence to GFD	one year