Can constipation drugs reveal hidden signals in gut tissue?
NCT ID NCT05107219
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study looked at how two approved constipation drugs, plecanatide and linaclotide, affect a chemical called cGMP in the small intestine. Researchers compared tissue samples from 43 adults with Barrett esophagus or GERD who took either drug or no drug. The goal was to measure cGMP levels, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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43 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Scheduled for clinically indicated esophagogastroduodenoscopy (EGD) * Age \>= 18 years of age. Note: Because no dosing or adverse event (AE) data are currently available on the use of plecanatide or linaclotide in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable * Willing to provide mandatory biospecimens as specified in the protocol * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Not pregnant or breastfeeding, as determined by pregnancy test prior to EGD procedure. Note: The effects of plecanatide and linaclotide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 2 weeks after discontinuing study agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Breastfeeding should be discontinued if the mother is treated with plecanatide or linaclotide * Ability to understand and the willingness to sign a written informed consent document * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible Exclusion Criteria: * Prior treatment in the past week with plecanatide, linaclotide, or other agent whose primary mechanism of action is that of a GCC agonist * History of allergic reactions attributed to compounds of similar chemical or biologic composition of plecanatide or linaclotide * Use of any other investigational agents =\< 12 weeks prior to registration * Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements * History of gastric bypass, gastric sleeve, or bariatric surgery
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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Other studies related to the condition(s) this trial covers.
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