Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients
I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission
1 other identifier
observational
70
1 country
1
Brief Summary
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
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
First Submitted
Initial submission to the registry
August 6, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 4, 2017
October 1, 2017
1.7 years
August 6, 2017
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
I-FABP levels at diagnosis
Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
1 day of enrollment
I-FABP levels during remission
Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)
6 months & 12 months after enrollment
Study Arms (2)
Test Group
Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher.
Control Group
Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0.
Eligibility Criteria
Pediatric patients undergoing endoscopy at the research hospital.
You may qualify if:
- Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.
You may not qualify if:
- Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
- Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
- NSAID use in the last week.
- Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
- Known genetic disorders (such as Down's syndrome).
- Patients whose TTG was elevated but lower than 3 times the normal range.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raanan Shamir, Prof
Director
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research fellow
Study Record Dates
First Submitted
August 6, 2017
First Posted
August 9, 2017
Study Start
November 1, 2017
Primary Completion
August 1, 2019
Study Completion
August 1, 2020
Last Updated
October 4, 2017
Record last verified: 2017-10