Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02226484 · ClinicalTrials.gov registry record · Phase 1
Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?
A Phase 1 study of Gastroesophageal Reflux Disease and GERD, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02226484: Completed Phase 1 study of Gastroesophageal Reflux Disease and GERD, sponsored by University of North Carolina, Chapel Hill.
NCT02226484 is a Phase 1 study of Gastroesophageal Reflux Disease and GERD that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 26 participants, below the 355-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02226484, a Phase 1 study of Gastroesophageal Reflux Disease and GERD, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: 1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and 2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by improvement in the barrier function and acid resistance of the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD) If interested, participants will be consented and provided a questionnaire to complete as part of the study. Participants will undergo endoscopy for routine care and will have up to 8 esophageal biopsies (small tissue samples) taken for the research study. After endoscopy, participants will be contacted to begin a 6 week treatment period with study drug (Quercetin, taken twice daily). At the end of the 6 week period, participants will be scheduled to have blood drawn and to have a follow-up endoscopy with biopsies performed for the research study.
Primary Outcome
To assess the change in claudin-4 levels in a given subject before and after administration of Quercetin (Q), our null hypothesis is that there will be no difference in claudin-4 levels (i.e. mean Δ of claudin-4 titer from t0 to t1 is 0) and the alternative hypothesis is that claudin-4 levels following the administration of Q will be significantly different than before administration. To test this hypothesis, we will perform paired Student's t-tests. If data violate normality, Wilcoxon signed-ra
Conditions Studied
Interventions
- DRUG Quercetin
Study Locations (1)
North Carolina
- UNC Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02226484 record still lists
NCT02226484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 355-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which Quercetin is the first listed.
NCT02226484 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02226484 about?
NCT02226484 is a clinical study titled "Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?". Purpose: 1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and 2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by improvement in the barrier func...
What is the current status of trial NCT02226484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-08. Estimated completion is 2016-06.
What conditions does trial NCT02226484 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease, GERD, Reflux, Acid Reflux.
What interventions are being tested in trial NCT02226484?
The interventions under investigation include: Quercetin (DRUG).
Who is sponsoring clinical trial NCT02226484?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02226484 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux Disease
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 NCT02226484's enrollment target sits among peer trials
26 23rd of 25 higher than 3 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease 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
-
GCC Agonist Signal in the Small Intestine
ACTIVE NOT RECRUITING · Phase 1
-
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
COMPLETED · Phase 1
-
Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
COMPLETED · Phase 1
-
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
RECRUITING · NA
-
Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry
RECRUITING
-
Domperidone in Treating Patients With Gastrointestinal Disorders
RECRUITING · Phase 3
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
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia