Gastroesophageal Reflux DiseaseNCT01249482
Symptom Assessment for GERD Patients Receiving H. Pylori Eradication
An observational study of Gastroesophageal Reflux Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Helicobacter pylori, reflux, acid rebound
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after PPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startSep 2010
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Chia Lee, MD,PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249482
- Sponsor's protocol ID
- 201008001M
- Status last verified
- Nov 2010
- First submitted
- 25 Nov 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT01249482
- Acronym / sponsor ID
- 201008001M
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Helicobacter pylori, reflux, acid rebound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Study completion
- Aug 2012 (estimated)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chia Lee, MD,PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chia Lee, MD,PhD (886-2-23123456 ext. 63351, yichialee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of acid-related symptoms with GerdQ (time frame: 2 weeks after PPI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2010.