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Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

Primary Purpose

Abdominal Pain, Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
synthetic human secretin
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    ChiRhoStim Group 1

    ChiRhoStim Group 2

    Arm Description

    Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.

    Patients undergoing diagnostic EGD that consent to undergo ePFT.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 9, 2020
    Last Updated
    January 13, 2020
    Sponsor
    Orlando Health, Inc.
    Collaborators
    ChiRhoClin, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04231279
    Brief Title
    Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
    Official Title
    Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Orlando Health, Inc.
    Collaborators
    ChiRhoClin, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Pain, Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ChiRhoStim Group 1
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.
    Arm Title
    ChiRhoStim Group 2
    Arm Type
    Experimental
    Arm Description
    Patients undergoing diagnostic EGD that consent to undergo ePFT.
    Intervention Type
    Drug
    Intervention Name(s)
    synthetic human secretin
    Other Intervention Name(s)
    ChiRhoStim
    Intervention Description
    Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
    Primary Outcome Measure Information:
    Title
    Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
    Description
    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).
    Time Frame
    2.5 years
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    This includes immunological and genetic markers.
    Time Frame
    2.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katelyn Kern, RN, BSN
    Phone
    321-841-9560
    Email
    Katelyn.Kern@orlandohealth.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Devendra Mehta, MD
    Organizational Affiliation
    Orlando Health, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency

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