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

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

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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.

Who Can Participate?

Eligibility

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 Range

0-17

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Prospective Evaluation of Exocrine Pancreatic Insufficiency in Pediatric Patients with Celiac Disease Using Endoscopic Pancreatic Function Testing

Principal Investigator

Arun
Ajmera

Protocol Number

PRO00117604

NCT ID

NA

Phase

N/A

Enrollment Status

Pending Open to Enrollment