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

NCT ID: NCT03663309

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2021-06-03

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 .

Conditions

Celiac Disease in Children

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

detecting Gluten peptides in faecal and urine samples

Intervention Type: 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

control group

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

No interventions assigned to this group

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

raanan shamir

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liron Mondshine, B.Sc

Role: STUDY_CHAIR

Rabin Medical Center

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

0367-17RMC

Identifier Type: -

Identifier Source: org_study_id