Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03244254|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : October 4, 2017
|Condition or disease|
|Celiac Disease in Children|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission|
|Estimated Study Start Date :||November 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
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.
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.
- I-FABP levels at diagnosis [ Time Frame: 1 day of enrollment ]Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
- I-FABP levels during remission [ Time Frame: 6 months & 12 months after enrollment ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244254
|Contact: Assaf Hoofien, Dr.||972523310096||Laerites@gmail.com|
|Contact: Raanan Shamir, Prof.||RaananS@clalit.org.il|
|Schneider Children's Medical Center of Israel||Not yet recruiting|
|Petaẖ Tiqwa, Israel|
|Contact: Assafh Hoofien, Dr. 9720523310096 Laerites@gmail.com|
|Study Director:||Raanan Shamir, Prof||Director|