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Symptom Assessment for GERD Patients Receiving H. Pylori Eradication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01249482
First received: November 25, 2010
Last updated: December 10, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The incidence and severity of acid-related symptoms with GerdQ [ Time Frame: 2 weeks after PPI ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: August 2012
Groups/Cohorts
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.

Detailed Description:

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 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 Patients and methods: Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic. After determination of H. pylori status by urea breath test, those with positive H. pylori infection will be randomized into two groups. Group A (n=100) will be given initial H. pylori eradication with triple therapy for one week, followed by proton-pump inhibitor (PPI) with rabeprazole 20 mg qd for 7 weeks. 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. 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. The incidence and severity of acid-related symptoms will be evaluated with GerdQ at 2 weeks after discontinuation of PPI. The impact of H. pylori infection and H. pylori eradication on the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor will be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Symptomatic reflux patients with high grade erosive esophagitis ( Los Angeles classification Grade C and D) or Barrett's esophagus documented by endoscopy.
  2. Symptomatic reflux patients with a history of using PPI in recent one month.
  3. Subjects with known allergy to PPI.
  4. Peptic ulcer disease
  5. Cancers of the esophagus, stomach, and duodenum
  6. Esophageal or gastric varices
  7. Active upper gastrointestinal bleeding within 7 days prior to enrollment
  8. Status after total or subtotal gastrectomy
  9. Pregnancy
  10. Use of anticoagulants or antiplatelets within one week prior to enrollment
  11. Subjects with bleeding tendency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249482

Contacts
Contact: Yi-Chia Lee, MD,PhD 886-2-23123456 ext 63351 yichialee@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yi-Chia Lee, MD,PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yi-Chia Lee, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01249482     History of Changes
Other Study ID Numbers: 201008001M
Study First Received: November 25, 2010
Last Updated: December 10, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
reflux
acid rebound

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013