Exocrine Pancreatic InsufficiencyPhase 4NCT07285863
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
A Phase 4 study testing Secretin (human synthetic) - ChiRhoClin in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
- What is being tested?
- Secretin (human synthetic) - ChiRhoClin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Regular use of anticholinergics
- > 2 drinks of alcohol daily
- Smokers (cigarette)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Being tested
- Secretin (human synthetic) - ChiRhoClin
- Keywords
- pancreatic function test, Pancreatic fluid composition
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretin (human synthetic) - ChiRhoClinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Healthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. 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. Receives: Drug: Secretin (human synthetic) - ChiRhoClin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic Fluid Bicarbonate Composition
A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5, 10, 15, and 20-minutes post-secretin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start11 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ChiRhoClin, Inc.
- Responsible party
- Principal investigator, Samuel Han, Mayo Clinic
- Investigators
- Samuel Han, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285863
- Sponsor's protocol ID
- 25-011644
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants
- ClinicalTrials.gov ID
- NCT07285863
- Acronym / sponsor ID
- 25-011644
- Keywords
- pancreatic function test, Pancreatic fluid composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- ChiRhoClin, Inc.
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Drug: Secretin (human synthetic) - ChiRhoClinHealthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secretin (human synthetic) - ChiRhoClinDuring 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 | Drug | Healthy Participants |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Han, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secretin (human synthetic) - ChiRhoClin in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic Fluid Bicarbonate Composition (time frame: 5, 10, 15, and 20-minutes post-secretin administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.