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. Identifier: NCT03244254
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : October 4, 2017
Information provided by (Responsible Party):
Dr. Assaf Hoofien, Schneider Children's Medical Center, Israel

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.

Condition or disease
Celiac Disease in Children

Detailed Description:
I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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.

Primary Outcome Measures :
  1. 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.

  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients undergoing endoscopy at the research hospital.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03244254

Contact: Assaf Hoofien, Dr. 972523310096
Contact: Raanan Shamir, Prof.

Schneider Children's Medical Center of Israel Not yet recruiting
Petaẖ Tiqwa, Israel
Contact: Assafh Hoofien, Dr.    9720523310096   
Sponsors and Collaborators
Schneider Children's Medical Center, Israel
Study Director: Raanan Shamir, Prof Director

Responsible Party: Dr. Assaf Hoofien, Research fellow, Schneider Children's Medical Center, Israel Identifier: NCT03244254     History of Changes
Other Study ID Numbers: SchneiderCMCIsraelIFABP
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Assaf Hoofien, Schneider Children's Medical Center, Israel:
Celiac Disease

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases