Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05107219 · ClinicalTrials.gov registry record · Phase 1
GCC Agonist Signal in the Small Intestine
A Phase 1 study of Barrett Esophagus and Gastroesophageal Reflux Disease, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 4
- Study locations
NCT05107219: Active Phase 1 study of Barrett Esophagus and Gastroesophageal Reflux Disease, sponsored by University of Wisconsin, Madison.
NCT05107219 is a Phase 1 study of Barrett Esophagus and Gastroesophageal Reflux Disease that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 43 participants, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05107219, a Phase 1 study of Barrett Esophagus and Gastroesophageal Reflux Disease, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 4
- Study locations
Study Summary
This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.
Primary Outcome
Will compare cGMP levels measured in normal-appearing duodenal mucosa biopsy specimens from participants receiving linaclotide or plecanatide to cGMP levels in specimens from participants receiving no active treatment. Will evaluate the difference between the control and each treated arm in cGMP levels using two-tailed two-sample Student t-tests. If necessary, a log transformation or Wilcoxon rank-sum will be used, as appropriate.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- PROCEDURE Esophagogastroduodenoscopy
- DRUG Linaclotide
- DRUG Plecanatide
Study Locations (4)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Arizona
- Mayo Clinic in Arizona - Scottsdale
Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 1 |
What the registry record for NCT05107219 still lists
NCT05107219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Barrett Esophagus appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05107219 reports a single indexed study location in Pennsylvania, Arizona, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05107219 about?
NCT05107219 is a clinical study titled "GCC Agonist Signal in the Small Intestine". This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking eit...
What is the current status of trial NCT05107219?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2022-11-30. Estimated completion is 2026-02-28.
What conditions does trial NCT05107219 study?
This clinical trial studies the following conditions: Barrett Esophagus, Gastroesophageal Reflux Disease, Malignant Digestive System Neoplasm.
What interventions are being tested in trial NCT05107219?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Esophagogastroduodenoscopy (PROCEDURE), Linaclotide (DRUG), Plecanatide (DRUG).
Who is sponsoring clinical trial NCT05107219?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05107219 being conducted?
This trial has 4 study locations across Arizona, Pennsylvania, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barrett Esophagus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05107219's enrollment target sits among peer trials
43 26th of 32 higher than 7 of 32 other Barrett Esophagus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
RECRUITING · NA
-
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
RECRUITING · NA
-
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
RECRUITING
-
Longitudinal Oral Microbiome Sampling for BE
RECRUITING
-
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
RECRUITING · NA
-
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03726359 · 43 participants · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
- NCT03850418 · 43 participants · Phase 2
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
- NCT04144023 · 43 participants · Phase 1
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
- NCT04176718 · 43 participants · Phase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI