Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

A Phase II Study to Identify the Role of Exocrine Pancreatic Insufficiency in Pediatric Patients With Abdominal Pain (RAP) Who Are Undergoing Upper Endoscopy Using Synthetic Human Secretin

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).

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome; Abdominal Pain
• Intervention / Treatment: Drug: synthetic human secretin

Detailed Description

Recurrent abdominal pain (RAP) is an often encountered complaint in children and adolescents. The evaluation of the child or adolescent with recurrent abdominal pain requires an understanding of the pathogenesis of abdominal pain, the most common causes of abdominal pain, and the typical patterns of presentation.

Children and adolescents frequently undergo esophagogastroduodenoscopy (EGD) to evaluate complaint and recurrent abdominal pain is a frequently cited reason for endoscopy. This is a standard procedure where an endoscope is passed through the mouth, esophagus, stomach and into the first part of the small intestine. With the camera at the end of the endoscope, the endoscopist is able to see the gross appearance of the upper digestive tract. Small biopsy samples are collected from the small intestine, stomach and esophagus to evaluate for mucosal injury, irritation, infection or other anomalies that could be contributing to the patient's symptoms. This is helpful for evaluation of histological changes, but does not provide information about its function.

Pancreatic stimulation testing with secretagogue (secretin, cholecystokinin) administration, and direct pancreatic fluid collection is considered a gold standard to assess the exocrine pancreatic function. Indirect testing of pancreatic function such as with urine or stool has much lower sensitivity and specificity compared to direct pancreatic fluid collection.

This is a prospective study where patients undergoing investigative EGD will have endoscopic pancreatic function test (ePFT) with secretin.

There will be two groups:

The first group are patients that are undergoing EGD with ePFT for evaluation of suspected or established pancreatic insufficiency with symptoms such as failure to thrive or malabsorption. These patients are the ones that historically have had ePFT testing done to evaluate their pancreatic function.

The second group is all patients that are undergoing scheduled diagnostic EGD for other reasons that consent for pancreatic stimulation testing. These patients are usually undergoing EGD for a range of symptoms that frequently include recurrent abdominal pain, bloating, diarrhea, nausea and/or constipation. These patients do not typically have ePFT testing performed and is not usually thought to be part of the standard of care for this group.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health - Arnold Palmer Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ChiRhoStim Group 1; Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.	Drug: synthetic human secretin; Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.; Other Names: ChiRhoStim
Experimental: ChiRhoStim Group 2; Patients undergoing diagnostic EGD that consent to undergo ePFT.	Drug: synthetic human secretin; Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.; Other Names: ChiRhoStim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain	Secretin stimulated exocrine pancreatic enzyme activity will be measured in patients with abdominal pain who are undergoing upper endoscopy to identify those with insufficiency (EPI).	2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary biomarkers for exocrine pancreatic insufficiency in blood and pancreatic fluid will be measured to explore mechanisms involved leading to abdominal pain and become potential tests in future.	This includes immunological and genetic markers.	2.5 years

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Collaborators: ChiRhoClin, Inc.
• Investigators: Principal Investigator: Devendra Mehta, MD, Orlando Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Pancreatic Diseases; Irritable Bowel Syndrome; Abdominal Pain; Exocrine Pancreatic Insufficiency; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Secretin
• Other Study ID Numbers: RAP and EPI; 1804804 (Other Identifier: Orlando Health IRB #2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No