Helicobacter Pylori InfectionNCT03572777
Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.
A study testing Concomitant therapy and Hybrid therapy in people with Helicobacter Pylori Infection, run by Antonio Mestrovic at 1 site in Croatia.
Trial summary
The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection. The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Concomitant therapy and Hybrid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Apr 2018to 15 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
- written informed consent
Who cannot join
- age under 18
- previously treatment of Helicobacter pylori infection
- malignancy of stomach or other site
- history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
- significant underlying disease (renal failure, psychiatric disorders)
- history of allergic reactions to any medications used in study
Show all 9Show fewer
- refuse to participate in study
- breastfeeding and pregnancy
- quitting the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection
The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.
The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.
Read more
In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.
The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Concomitant therapy, Hybrid therapy
- Keywords
- Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant therapyDrug
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
Concomitant therapyDrug
Clarithromycin ('Makcin') 500 mg bid for 14 days
Concomitant therapyDrug
Metronidazole ('Medazol') 500 mg bid for 14 days
Concomitant therapyDrug
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapyDrug
Amoxicillin ('Amoksicilin') 1 g bid 14 days
Hybrid therapyDrug
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapyDrug
Clarithromycin ('Makcin') 500 mg bid for the last 7 days
Hybrid therapyDrug
Metronidazole ('Medazol') 500 mg bid for the last 7 days
| Study group | Role | What they receive |
|---|---|---|
| Concomitant therapy | Active comparator | Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days. Receives: Drug: Concomitant therapy |
| Hybrid therapy | Active comparator | Amoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days. Receives: Drug: Hybrid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori status one month after treatment.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
Measured: One month after finishing with therapy.
Secondary outcomes (2)
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance
Measured: One month after finishing with therapy.
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Patients will be ask to report any adverse effect occured during treatment. They will be divided in groups according to degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities).
Measured: One month after finishing with therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start15 Apr 2018
- Primary completion1 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Mestrovic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split, University of Split, School of Medicine
- Responsible party
- Sponsor-investigator, Antonio Mestrovic, University of Split, School of Medicine
- Investigators
- Antonio Meštrović, MD, Principal investigator, University Hospital Centre Split, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572777
- Sponsor's protocol ID
- 003-08/18-03/0001
- Status last verified
- Jan 2021
- First submitted
- 24 May 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mestrovic A, Perkovic N, Bozic J, Pavicic Ivelja M, Vukovic J, Kardum G, Puljiz Z, Tonkic A. Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection. PLoS One. 2020 Dec 30;15(12):e0244500. doi: 10.1371/journal.pone.0244500. eCollection 2020.
PubMed 33378403
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT03572777
- Acronym / sponsor ID
- 003-08/18-03/0001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Antonio MestrovicUniversity, hospital or other
- Collaborators
- University Hospital of Split, University of Split, School of Medicine
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 28 Jun 2018 (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 aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.
The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.
In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.
The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant therapy | Active comparator | Drug: Concomitant therapyAmoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days. |
| Hybrid therapy | Active comparator | Drug: Hybrid therapyAmoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
- written informed consent
Key exclusion criteria (9 listed)
- age under 18
- previously treatment of Helicobacter pylori infection
- malignancy of stomach or other site
- history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
- significant underlying disease (renal failure, psychiatric disorders)
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 |
|---|---|---|
| Concomitant therapyAmoxicillin ('Amoksicilin') 1 g bid 14 days. | Drug | Concomitant therapy |
| Concomitant therapyClarithromycin ('Makcin') 500 mg bid for 14 days | Drug | Concomitant therapy |
| Concomitant therapyMetronidazole ('Medazol') 500 mg bid for 14 days | Drug | Concomitant therapy |
| Concomitant therapyEsomeprazole ('Emanera') 40 mg bid for 14 days | Drug | Concomitant therapy |
| Hybrid therapyAmoxicillin ('Amoksicilin') 1 g bid 14 days | Drug | Hybrid therapy |
| Hybrid therapyEsomeprazole ('Emanera') 40 mg bid for 14 days | Drug | Hybrid therapy |
| Hybrid therapyClarithromycin ('Makcin') 500 mg bid for the last 7 days | Drug | Hybrid therapy |
| Hybrid therapyMetronidazole ('Medazol') 500 mg bid for the last 7 days | Drug | Hybrid therapy |
Primary outcome
Helicobacter pylori status one month after treatment.
Time frame: One month after finishing with therapy.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
2 secondary outcomes
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Time frame: One month after finishing with therapy.
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Time frame: One month after finishing with therapy.
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 26 Jan 2021.
- Derived from this study: PubMed 33378403Mestrovic A, Perkovic N, Bozic J, Pavicic Ivelja M, Vukovic J, Kardum G, Puljiz Z, Tonkic A. Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection. PLoS One. 2020 Dec 30;15(12):e0244500. doi: 10.1371/journal.pone.0244500. eCollection 2020.
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.
Antonio Meštrović, MD principal investigator
University Hospital Centre Split, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concomitant therapy and Hybrid therapy in people with Helicobacter Pylori Infection, run by Antonio Mestrovic at 1 site in Croatia.
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 9 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 26 Jan 2021. 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 Croatia. 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?
Helicobacter pylori status one month after treatment. (time frame: One month after finishing with therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572777, which also lists 1 linked publication.
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 Jan 2021.