Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication

NCT02934152 | Unknown Phase 4

• 1 other identifier: 201607055MINC
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of proton-pump inhibitor has been reported in previous studies. In patients with concurrent gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of H. pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor (PPI) remains elusive Objective: This study aims to investigate the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication Expected result: The investigators will find out the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Acid rebound

  Development of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication

  4 weeks

Secondary Outcomes (1)

• Severity of acid rebound

  4 weeks

Study Arms (3)

Early eradication

EXPERIMENTAL

Group A (H pylori eradication timing: early eradication, n=100): Initial H pylori eradication with triple therapy (rabeprazole 20 mg qd, amoxicillin 1gm bid, clarithromycin 500 mg bid) for two weeks.

Drug: H pylori eradication; Other: H pylori eradication timing

Late eradication

EXPERIMENTAL

Group B (H pylori eradication timing: late eradication, n=100): PPI with rabeprazole 20 mg qd for 4 weeks, followed by H pylori eradication with triple therapy for two weeks

Drug: H pylori eradication; Other: H pylori eradication timing

Negative Hp

ACTIVE COMPARATOR

For patients with negative H. p infection documented by UBT (Group C, n=200), No H pylori eradication treatment will be given but PPI with rabeprazole 20 mg qd will be given for 8 weeks.

Drug: H pylori eradication

Interventions

H pylori eradication DRUG

H pylori eradication

Also known as: rabeprazole, amoxicillin, clarithromycin

Early eradication; Late eradication; Negative Hp

H pylori eradication timing OTHER

Early or late eradication

Early eradication; Late eradication

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated by standard questionnaire GerdQ.16
• Aged \>= 20 years old.
• Willing to receive H. pylori eradication therapy.

You may not qualify if:

• Symptomatic reflux patients with high grade erosive esophagitis (LA classification Grade C and D) or Barrett's esophagus documented by endoscopy.
• Symptomatic reflux patients with a history of using PPI in recent one month.
• Subjects with known allergy to PPI.
• Peptic ulcer disease
• Cancers of the esophagus, stomach, and duodenum
• Esophageal or gastric varices
• Active upper gastrointestinal bleeding within 7 days prior to enrollment
• Status after total or subtotal gastrectomy
• Pregnancy
• Use of anticoagulants or antiplatelets within one week prior to enrollment
• Subjects with bleeding tendency

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (1)

• Hu KY, Tseng PH, Liou JM, Tu CH, Chen CC, Lee YC, Chiu HM, Wu MS. Rebound of Reflux-Related Symptoms After Helicobacter pylori Eradication in Patients With Gastroesophageal Reflux Disease: A Prospective Randomized Study. Helicobacter. 2025 Jan-Feb;30(1):e70023. doi: 10.1111/hel.70023.

  PMID: 40007457 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Ping-Huei Tseng, MDPHD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping-Huei Tseng, MDPHD

CONTACT

886-972652009; pinghuei@ntu.edu.tw

Yen-Hsi Hsu

CONTACT

886-2-23123456

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)