Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.
1 other identifier
observational
194
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2018
CompletedFirst Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2021
CompletedOctober 1, 2021
September 1, 2021
3 years
September 6, 2018
September 30, 2021
Conditions
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.
control group
Healthy controls aged 2-17 years old matched for age and sex.
Interventions
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, 49202, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liron Mondshine, B.Sc
Rabin Medical Center
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