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NCT Number: NCT07285863

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

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.

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Key information

Conditions

Exocrine Pancreatic Insufficiency Chronic Disease Chronic Pancreatitis Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Liz Lemke

CONTACT

507-266-3317

Samuel Han, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Secretin (human synthetic) - ChiRhoClin

Drug

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

Primary outcomes

  1. Pancreatic Fluid Bicarbonate Composition

    Time frame: 5, 10, 15, and 20-minutes post-secretin administration

    A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.

  2. Pancreatic Fluid Sodium Composition

    Time frame: 5, 10, 15, and 20-minutes post-secretin administration

    A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.

  3. Pancreatic Fluid Potassium Composition

    Time frame: 5, 10, 15, and 20-minutes post-secretin administration

    A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.

  4. Pancreatic Fluid Chloride Composition

    Time frame: 5, 10, 15, and 20-minutes post-secretin administration

    A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Liz Lemke

CONTACT

[email protected]

507-266-3317

Samuel Han, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • ChiRhoClin, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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