DyspepsiaPhase 4NCT04449185
Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
A Phase 4 study testing Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days in people with Dyspepsia, run by Asan Medical Center.
Trial summary
The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2020to 30 Oct 2021
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who has diagnosed with functional dyspesia by Rome IV criteria
Who cannot join
- Known GI malignancy
- Previous Helicobater pylori eradication history
- Severe systemic disease
- Previous GI surgery
- Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml
- Pregnant or breastfeeding women
- Atrophic gastritis, open type
Trial locations and contacts
No sites are listed yet.
About this study
The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
Read the detailed description
Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
- Conditions
- Dyspepsia
- Being tested
- Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
- Keywords
- Dyspepsia, Microbiome, Eradication therapy
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 daysDrug
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
| Study group | Role | What they receive |
|---|---|---|
| HP eradication group | Experimental | HP eradication group
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days Receives: Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gut microbiome
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
Measured: at 3 months, and 6 months
Secondary outcomes (3)
Symptom of dyspepsia
Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
Measured: at 3 months, and 6 months
Eradication of helicobacter pylori
Eradication rate of helicobacter pylori at 3 months
Measured: at 3 months
Histologic finding of UGI tract
Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
Measured: at initial and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kee Wook Jung, Asan Medical Center
- Investigators
- Kee Wook Jung, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449185
- Sponsor's protocol ID
- 2020-0621
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT04449185
- Acronym / sponsor ID
- 2020-0621
- Conditions
- Dyspepsia
- Keywords
- Dyspepsia, Microbiome, Eradication therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 26 Jun 2020 (actual)
- 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.
The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
Detailed description
Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP eradication group | Experimental | Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 daysHP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who has diagnosed with functional dyspesia by Rome IV criteria
Key exclusion criteria (7 listed)
- Known GI malignancy
- Previous Helicobater pylori eradication history
- Severe systemic disease
- Previous GI surgery
- Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml
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 |
|---|---|---|
| Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 daysTegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days | Drug | HP eradication group |
Primary outcome
Change of gut microbiome
Time frame: at 3 months, and 6 months
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
3 secondary outcomes
Symptom of dyspepsia
Time frame: at 3 months, and 6 months
Eradication of helicobacter pylori
Time frame: at 3 months
Histologic finding of UGI tract
Time frame: at initial and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Kee Wook Jung, MD, PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days in people with Dyspepsia, run by Asan Medical Center.
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 1 inclusion and 7 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kee Wook Jung, MD, PhD (821026778856, jung.keewook30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gut microbiome (time frame: at 3 months, and 6 months). 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 26 Jun 2020.