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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07285863
Enrollment
24
Registered
2025-12-16
Start date
2026-03-11
Completion date
2028-03-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Exocrine Pancreatic Insufficiency

Keywords

pancreatic function test, Pancreatic fluid composition

Brief summary

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.

Interventions

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

Sponsors

Mayo Clinic
Lead SponsorOTHER
ChiRhoClin, Inc.
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pancreatic Fluid Bicarbonate Composition5, 10, 15, and 20-minutes post-secretin administrationA primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Sodium Composition5, 10, 15, and 20-minutes post-secretin administrationA primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Potassium Composition5, 10, 15, and 20-minutes post-secretin administrationA primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.
Pancreatic Fluid Chloride Composition5, 10, 15, and 20-minutes post-secretin administrationA primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.

Countries

United States

Contacts

CONTACTLiz Lemke
Lemke.Elizabeth@mayo.edu507-266-3317
CONTACTSamuel Han, MD
han.samuel@mayo.edu
PRINCIPAL_INVESTIGATORSamuel Han, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026