Helicobacter Pylori InfectionPhase 4NCT03997279
Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii
A Phase 4 study testing Saccharomyces boulardii in people with Helicobacter Pylori Infection, run by Clinical Centre of Serbia.
Trial summary
This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Saccharomyces boulardii
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Dyspepsia
- Patients not treated for H. Pylori
- Age of 18-50 years
- Positive urea breath test
Who cannot join
- Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen)
- Gastric cancer
- Immunosuppressive therapy
- Use of acetylsalicylic acid
- Severe renal failure
- Severe liver failure
Show all 13Show fewer
- Immunodeficiency
- Proven malignant disease
- Penicillin allergy
- Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D)
- Chronic alcoholism
- Pregnancy
- Lactation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic
This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.
Read the detailed description
Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy.
The study was designed as a prospective, double-blind, randomized, case-control intervention study.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Saccharomyces boulardii, Placebo
- Keywords
- Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDrug
Also called Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week
PlaceboDrug
Also called Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week
| Study group | Role | What they receive |
|---|---|---|
| S.boulardi | Experimental | Quadruple eradication therapy with S. boulardi Receives: Drug: Saccharomyces boulardii |
| Placebo | Placebo comparator | Quadruple eradication therapy without S. boulardi Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of urea breath test (Eradication of H.pylori)
Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)
Measured: baseline to 8 weeks after the introduction of the therapy
Secondary outcomes (2)
Side effects of eradication therapy
Number and severity of adverse events of standard eradication therapy
Measured: baseline to 8 weeks after the introduction of the therapy
Compliance of eradication therapy
Patient successfully completed prescribed therapy
Measured: baseline to 8 weeks after the introduction of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miodrag Krstic, Clinical Centre of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997279
- Sponsor's protocol ID
- AB-2019-4
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic
- ClinicalTrials.gov ID
- NCT03997279
- Acronym / sponsor ID
- AB-2019-4
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 25 Jun 2019 (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.
This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.
Detailed description
Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy.
The study was designed as a prospective, double-blind, randomized, case-control intervention study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S.boulardi | Experimental | Drug: Saccharomyces boulardiiQuadruple eradication therapy with S. boulardi |
| Placebo | Placebo comparator | Drug: PlaceboQuadruple eradication therapy without S. boulardi |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Dyspepsia
- Patients not treated for H. Pylori
- Age of 18-50 years
- Positive urea breath test
Key exclusion criteria (13 listed)
- Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen)
- Gastric cancer
- Immunosuppressive therapy
- Use of acetylsalicylic acid
- Severe renal failure
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 |
|---|---|---|
| Saccharomyces boulardiiAlso: Rabeprazole, Amoxicillin, Clarithromycin, MetronidazoleRabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week | Drug | S.boulardi |
| PlaceboAlso: Rabeprazole, Amoxicillin, Clarithromycin, MetronidazoleRabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week | Drug | Placebo |
Primary outcome
Result of urea breath test (Eradication of H.pylori)
Time frame: baseline to 8 weeks after the introduction of the therapy
Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)
2 secondary outcomes
Side effects of eradication therapy
Time frame: baseline to 8 weeks after the introduction of the therapy
Compliance of eradication therapy
Time frame: baseline to 8 weeks after the introduction of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saccharomyces boulardii in people with Helicobacter Pylori Infection, run by Clinical Centre of Serbia.
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 4 inclusion and 13 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 25 Jun 2019. 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. Some participants in this study may receive a placebo. 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 Miodrag Krstic, MD, PhD (+381113615575, krstic.miodrag61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of urea breath test (Eradication of H.pylori) (time frame: baseline to 8 weeks after the introduction of the therapy). 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 25 Jun 2019.