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

November 25, 2010
December 10, 2010
September 2010
Not Provided
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
Same as current
Complete list of historical versions of study NCT01249482 on ClinicalTrials.gov Archive Site
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Symptom Assessment for GERD Patients Receiving H. Pylori Eradication
Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

Gastroesophageal Reflux Disease
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2012
Not Provided

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
Both
18 Years to 70 Years
No
Contact: Yi-Chia Lee, MD,PhD 886-2-23123456 ext 63351 yichialee@ntu.edu.tw
Taiwan
 
NCT01249482
201008001M
No
Yi-Chia Lee, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Yi-Chia Lee, MD,PhD National Taiwan University Hospital
National Taiwan University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP