Helicobacter Pylori InfectionNCT02359942
The Diagnostic Validity of the Urea Breath Test
A study testing Citric acid in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
1. To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest and H. pylori culture). 2. To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Citric acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2015to 31 Dec 2018
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female Korean adult (Aged over 18 years)
- The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy
Who cannot join
- Age under 18 years
- Patients who took any drug which could affect the study results such as proton pump inhibitor, H2 blocker, mucosal protective agents and antibiotics
- Advanced gastric cancer or other malignancy
- Abnormal liver function test or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Other severe concurrent disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Citric Acid as the Test Meal on the Diagnostic Accuracy of the 13C-Urea Breath Test in Korean, Randomized Controlled, Open Label Prospective Study
- To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest and H. pylori culture).
- To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.
Read the detailed description
1-1 Screening (visit 1, From -6 to -8 weeks) and H. pylori eradication
- To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
- H. pylori eradication
- First eradication: PPI-based triple therapy (standard dose of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 1 week), and sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d)
- Rescue therapy: bismuth-containing quadruple therapy [PPI b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.] for 1-2 weeks, or moxifloxacin-containing triple therapy (moxifloxacin 400 mg q.d., amoxicillin 1g b.i.d., and PPI b.i.d.) for 1-2 weeks.
1-2 Baseline (visit 2, 0 week): urea breath test
- Reconfirm inclusion and exclusion criteria
- Randomization for UBT test (citric acid group vs control group)
- In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
- Perform UBT in both group
1-3) Endoscopic surveillance (visit 3, 6 or later months)
- Endoscopic surveillance for final H. pylori status after UBT
- Histology, CLOtest or H. pylori culture
- Statical analysis for diagnostic accuracy of the UBT between citric acid group and controlled group: sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, and false negative rate.
- Selecting 40 patients who showed UBT result between 2.5 to 4.0 in controlled group, the investigators are planning to reperform 13C-UBT after giving citric acid as test meal.
And then, the investigators compare the change of UBT result before and after ingestion citric acid as test meal.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Citric acid
- Keywords
- Helicobacter pylori infection, Eradication, Urea breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric acidDrug
Giving the citric acid (4g) solving in 200 ml of water before UBT
| Study group | Role | What they receive |
|---|---|---|
| Citric acid group | Experimental | Giving the citric acid (4g) as test meal before UBT Receives: Drug: Citric acid |
| Controlled group | No intervention | No use of test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group
After urea breath test in the two group (citric acid group vs controlled group), endoscopic surveillance would be performed for confirmation of H. pylori status by endoscopic biopsy methods(histology, CLOtest or culture).
Measured: 6 months or later after urea breath test
Compare the diagnostic accuracy which is a composite outcome measure such as sensitivity, specificity, predictive positive value and negative predictive value between citric acid group and controlled group
Comparing the final H. pylori status between UBT method and endoscopic biopsy methods, we will evaluate the diagnostic accuracy (sensitivity, specificity, false positive ratio, false negative ratio, positive predictive value and negative predictive value) of the UBT between using citric acid group and controlled group.
Measured: 6 months or later after urea breath test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start1 Mar 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359942
- Sponsor's protocol ID
- B-1412/279-004
- Status last verified
- Apr 2019
- First submitted
- 18 Jan 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citric Acid as the Test Meal on the Diagnostic Accuracy of the 13C-Urea Breath Test in Korean, Randomized Controlled, Open Label Prospective Study
- ClinicalTrials.gov ID
- NCT02359942
- Acronym / sponsor ID
- B-1412/279-004
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori infection, Eradication, Urea breath test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Feb 2015 (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.
- To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest and H. pylori culture).
- To compare the delta value of 13CO2 results between before and after ingestion of citric acid as test meal.
Detailed description
1-1 Screening (visit 1, From -6 to -8 weeks) and H. pylori eradication
- To accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients
- H. pylori eradication
- First eradication: PPI-based triple therapy (standard dose of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 1 week), and sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d)
- Rescue therapy: bismuth-containing quadruple therapy [PPI b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.] for 1-2 weeks, or moxifloxacin-containing triple therapy (moxifloxacin 400 mg q.d., amoxicillin 1g b.i.d., and PPI b.i.d.) for 1-2 weeks.
1-2 Baseline (visit 2, 0 week): urea breath test
- Reconfirm inclusion and exclusion criteria
- Randomization for UBT test (citric acid group vs control group)
- In citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before UBT.
- Perform UBT in both group
1-3) Endoscopic surveillance (visit 3, 6 or later months)
- Endoscopic surveillance for final H. pylori status after UBT
- Histology, CLOtest or H. pylori culture
- Statical analysis for diagnostic accuracy of the UBT between citric acid group and controlled group: sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, and false negative rate.
- Selecting 40 patients who showed UBT result between 2.5 to 4.0 in controlled group, the investigators are planning to reperform 13C-UBT after giving citric acid as test meal.
And then, the investigators compare the change of UBT result before and after ingestion citric acid as test meal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citric acid group | Experimental | Drug: Citric acidGiving the citric acid (4g) as test meal before UBT |
| Controlled group | No intervention | –No use of test meal |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female Korean adult (Aged over 18 years)
- The Patients who diagnosed H. pylori infection and received H. pylori eradication therapy
Key exclusion criteria (6 listed)
- Age under 18 years
- Patients who took any drug which could affect the study results such as proton pump inhibitor, H2 blocker, mucosal protective agents and antibiotics
- Advanced gastric cancer or other malignancy
- Abnormal liver function test or liver cirrhosis
- Abnormal renal function or chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citric acidGiving the citric acid (4g) solving in 200 ml of water before UBT | Drug | Citric acid group |
Primary outcome
Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group
Time frame: 6 months or later after urea breath test
After urea breath test in the two group (citric acid group vs controlled group), endoscopic surveillance would be performed for confirmation of H. pylori status by endoscopic biopsy methods(histology, CLOtest or culture).
Compare the diagnostic accuracy which is a composite outcome measure such as sensitivity, specificity, predictive positive value and negative predictive value between citric acid group and controlled group
Time frame: 6 months or later after urea breath test
Comparing the final H. pylori status between UBT method and endoscopic biopsy methods, we will evaluate the diagnostic accuracy (sensitivity, specificity, false positive ratio, false negative ratio, positive predictive value and negative predictive value) of the UBT between using citric acid group and controlled group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citric acid in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who showed discrepant result between UBT result and endoscopic result in both citric acid group and controlled group (time frame: 6 months or later after urea breath test). The study lists 2 primary outcomes in all. 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 18 Apr 2019.