Symptom Assessment for GERD Patients Receiving H. Pylori Eradication

NCT01249482 | Unknown

• 1 other identifier: 201008001M
• Study Type: observational
• Target: 300
• 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 Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Helicobacter pylori; reflux; acid rebound

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of acid-related symptoms with GerdQ

  To compare the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor between reflux patients with and without H. pylori infection

  2 weeks after PPI

Study Arms (3)

Late eradication

Group B (n=100) will be given rabeprazole 20 mg qd for 8 weeks and discontinued for 2 weeks. Then, H. pylori eradication with triple therapy will be given for one week, followed by rabeprazole 20 mg qd for 7 weeks.

Negative HP

For patients with negative H. pylori infection (n=100), proton-pump inhibitor with rabeprazole 20 mg qd will be given for 8 weeks and discontinued.

Early eradication

Group A (n=100) will be given initial H. pylori eradication with triple therapy for one week, followed by proton-pump inhibitor with rabeprazole 20 mg qd for 7 weeks.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic.

You may qualify if:

• Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated by standard questionnaire GerdQ.16
• Aged from 18 to 70 years old.
• Willing to receive H. pylori eradication therapy.

You may not qualify if:

• Symptomatic reflux patients with high grade erosive esophagitis ( Los Angeles 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

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi-Chia Lee, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chia Lee, MD,PhD

CONTACT

886-2-23123456; yichialee@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: November 29, 2010
• Study Start: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: December 13, 2010

Record last verified: 2010-11

Locations

TW (1)