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

Mayo Clinic

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency

Treatments: Drug: Secretin (human synthetic) - ChiRhoClin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07285863

25-011644

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Healthy Participants

Experimental group

Description:

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.

Treatment:

Drug: Secretin (human synthetic) - ChiRhoClin