TerminatedPhase 3

Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

Stopped: Data collection discontinuity and sponsor reallocation of study resources to manufacturing

United States27 participantsStarted 2022-01-28

Plain-language summary

This is a 3-year prospective study too identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy. An endoscopic pancreatic function test (ePFT) with secretin will be performed in children undergoing routine investigative EGD. The goal of this study is to identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy, who otherwise would be labelled as recurrent abdominal pain (RAP).

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For Group 1- Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency * For Group 2- Patients undergoing diagnostic EGD who consent to undergo ePFT Exclusion Criteria: * If it is an emergency EGD procedure * If the caregiver refuses to sign the consent form * Patient has undergone ePFT testing previously with a documented allergy to human secretin * Patients that require atropine at the time of sedation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain

Timeframe: 2.5 years

Trial details

NCT IDNCT04231279

SponsorOrlando Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-15

View on ClinicalTrials.gov More Abdominal Pain trials