The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker

Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker.

A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Subepithelial Tumors
• Intervention / Treatment: Drug: Ilaprazole

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Older than 20 years old and younger than 80 years old
• Patients with typical reflux symptoms at least 2days per week (or GERD Q score ≥ 8 )
• No erosion at GE junction through endoscopy
• Patients that can perform a 24 hr - combined multichannel intraluminal impedance and pH esophageal monitoring prior to this study.

Exclusion Criteria:

• included prior history of documented intolerance of ilaprazole or similar PPIs, or
• unsuspected alarm symptoms such as weight loss, hematemesis, hematochezia, jaundice or other significant illness like malignancy
• alcoholism or drug addiction
• uncontrolled diabetes, cerebrovascular accident or diseases needed an operation in the last 3 months before enrollment
• any previous esophageal surgery
• malignancy in gastrointestinal tract within 5years
• pregnant woman
• Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal stricture, duodenal ulcer, gastric ulcer, pancreatitis, absorption disorder, severe cardiovascular disease, severe lung disease in the last 3 months before enrollment
• history of steadily taking medicine such as diazepam, quinidine, diphenylhydantoin, mephenytoin, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent, salicylate, steroid, pro-motility drug, nonsteroidal anti-inflammatory drugs(NSAIDS)
• patients who were registered other exams within 28days
• patients who could not conduct sedated endoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: ilaprazole group; ilaprazole 20mg once daily for 4 weeks.

Drug: Ilaprazole; Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of symptoms	All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of histopathological findings	Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.	4 weeks
changes of inflammatory biomarkers	Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.	4 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: January 24, 2016
• First Submitted That Met QC Criteria: January 24, 2016
• First Posted (ESTIMATE): January 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Gastroesophageal reflux, proton pump inhibitors, ilaprazole
• Other Study ID Numbers: 4-2014-0110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO