A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects

An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants

The purpose of this study is to collect pancreas fluid from the duodenum using the endoscopic pancreas function collection method in healthy participants after pancreatic stimulation with human secretin.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency
• Intervention / Treatment: Drug: Secretin (human synthetic) - ChiRhoClin

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liz Lemke; Phone Number: 507-266-3317; Email: Lemke.Elizabeth@mayo.edu
• Study Contact Backup: Name: Samuel Han, MD; Email: han.samuel@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Liz Lemke; Phone Number: 507-266-3317
      • Principal Investigator: Samuel Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Males or non-pregnant females
• Age 18-80.
• Participants must be in good health based on medical history (ASA Class 3 or below)
• Participants must be willing and able to provide informed consent
• Receiving an endoscopic ultrasound for a non-pancreatic indication

Exclusion Criteria

• History of any form of pancreatitis and/or other pancreatic diseases (e.g. pancreatic cysts, pancreatic masses).
• History of inflammatory bowel disease
• History of vagotomy.
• History of surgically altered upper gastrointestinal anatomy (e.g. gastric bypass, Billroth I/II)
• History of liver disease
• Pregnant women or nursing mothers
• Regular use of anticholinergics
• > 2 drinks of alcohol daily
• Smokers (cigarette)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Participants; Healthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. This arm will be stratified into 3 age groups: 18-35, 35-45, and 46+ years. Participants will be given a standard dose of intravenous human secretin (0.2 mcg/kg) during the endoscopic ultrasound. During this time, pancreatic fluid will be collected at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after secretin administration.

Drug: Secretin (human synthetic) - ChiRhoClin; During endoscopic ultrasound (EUS), a dose of intravenous secretin (0.2 µg/kg) will be administered over the course of 1 minute to stimulate pancreatic ductal cells to secrete pancreas fluid. Duodenal fluid will be aspirated through the echoendoscope in 5 minute increments (5, 10, 15, and 20 minutes) after the secretin has been administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic Fluid Bicarbonate Composition	A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.	5, 10, 15, and 20-minutes post-secretin administration
Pancreatic Fluid Sodium Composition	A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.	5, 10, 15, and 20-minutes post-secretin administration
Pancreatic Fluid Potassium Composition	A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.	5, 10, 15, and 20-minutes post-secretin administration
Pancreatic Fluid Chloride Composition	A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.	5, 10, 15, and 20-minutes post-secretin administration

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: ChiRhoClin, Inc.
• Investigators: Principal Investigator: Samuel Han, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pancreatic function test; Pancreatic fluid composition
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Gastrointestinal Hormones; Secretin
• Other Study ID Numbers: 25-011644

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.: Yes