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

NCT03663309 | Completed DMC

• 1 other identifier: 0367-17RMC
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

1. Children and adolescents aged 2-17 years, reported to be on gluten free diet for at least a year, diagnosed with celiac disease 2. Children and adolescents aged 2-17 years that are reported to be noncompliant with gluten free diet, diagnosed with celiac disease for at least 1 year.

Diagnostic Test: detecting Gluten peptides in faecal and urine samples

control group

Healthy controls aged 2-17 years old matched for age and sex.

Interventions

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

study group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

1. Children and adolescents aged 2-17 years, reported to be on gluten free diet for at least a year, diagnosed with celiac disease 2. Children and adolescents aged 2-17 years that are reported to be noncompliant with gluten free diet, diagnosed with celiac disease for at least 1 year. 3. Healthy controls aged 2-17 years old matched for age and sex.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

MeSH Terms

Interventions

Defecation

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Liron Mondshine, B.Sc

  Rabin Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: June 19, 2018
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

IL (1)