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Symptom Assessment for GERD Patients Receiving H. Pylori Eradication

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ClinicalTrials.gov Identifier: NCT01249482
Recruitment Status : Unknown
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 29, 2010
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

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.

Condition or disease
Gastroesophageal Reflux Disease

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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
Study Start Date : September 2010
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort
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.



Primary Outcome Measures :
  1. The incidence and severity of acid-related symptoms with GerdQ [ Time Frame: 2 weeks after PPI ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yi-Chia Lee, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01249482     History of Changes
Other Study ID Numbers: 201008001M
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: November 2010

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