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Prospective Evaluation of Exocrine Pancreatic Insufficiency (Celiac or Suspected Celiac Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how common it is for exocrine pancreatic insufficiency (EPI) to be present in children who have or are suspected to have celiac disease. We also want to compare different methods of testing for EPI in this study.

What is the Condition Being Studied?

Exocrine Pancreatic Insufficiency in the Setting of Celiac Disease

Who Can Participate in the Study?

Children ages 0-17 who:

  • Have a documented abnormal celiac serology test (elevated blood antibody levels that are associated with celiac disease)
  • Are scheduled to have an upper endoscopy to get a biopsy to confirm celiac disease
  • Have not started a gluten-free diet before having their diagnostic endoscopy

For more information, contact the study team at annette.babu@duke.edu.

Age Group
Children

What is Involved?

If your child choose to join this study with your permission, they will have their routine endoscopy performed to confirm whether or not they have celiac disease. This endoscopy will include endoscopic pancreatic function testing, which is also a routine, common test. Pancreatic fluid will be collected during the procedure following intravenous secretin administration. Additional research analysis will be conducted on the excess pancreatic fluid samples that would otherwise be discarded.

Study Details

Full Title
Prospective Evaluation of Exocrine Pancreatic Insufficiency in Pediatric Patients with Celiac Disease Using Endoscopic Pancreatic Function Testing
Principal Investigator
Pediatric Gastroenterologist
Protocol Number
IRB: PRO00117604
NCT: NA
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon