Helicobacter Pylori InfectionPhase 4NCT03220542
The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori
A Phase 4 study testing Probiotics, Broccoli and Esomeprazole in people with Helicobacter Pylori Infection, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Probiotics, Broccoli and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 31 Dec 2019
- 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
- Helicobacter pylori infected patients
- Patients with active or healing gastric/duodenal ulcers
Who cannot join
- prior Hp eradication therapy
- previous gastric resection
- previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
- Patients who were pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial
In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Probiotics, Broccoli, Esomeprazole, Amoxicillin, Clarithromycin
- Keywords
- Helicobacter Pylori, Probiotics, Sulforaphane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
Also called Bioflor 250, Kuhnil Pharmacy, Seoul, Korea
Saccharomyces boulardii
BroccoliDietary supplement
Also called Sulforaphane
Broccoli sprouts extract
EsomeprazoleDrug
Esomeprazole
AmoxicillinDrug
Amoxicillin
ClarithromycinDrug
Clarithromycin
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin Receives: Drug: Probiotics; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
| Broccoli | Experimental | Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin Receives: Dietary Supplement: Broccoli; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
| Triple Therapy | Active comparator | Esomeprazole + Amoxicillin + Clarithromycin Receives: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
Using the urea breath test
Measured: 5 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startJan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2019 (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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Wook Kim, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220542
- Sponsor's protocol ID
- Broccoli2014
- Status last verified
- May 2019
- First submitted
- 9 Jul 2017
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03220542
- Acronym / sponsor ID
- Broccoli2014
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, Probiotics, Sulforaphane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Jul 2017 (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.
In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: Probiotics, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarithromycinSaccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin |
| Broccoli | Experimental | Dietary Supplement: Broccoli, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarithromycinBroccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin |
| Triple Therapy | Active comparator | Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarithromycinEsomeprazole + Amoxicillin + Clarithromycin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori infected patients
- Patients with active or healing gastric/duodenal ulcers
Key exclusion criteria (4 listed)
- prior Hp eradication therapy
- previous gastric resection
- previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
- Patients who were pregnant or lactating
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 |
|---|---|---|
| ProbioticsAlso: Bioflor 250, Kuhnil Pharmacy, Seoul, KoreaSaccharomyces boulardii | Drug | Probiotics |
| BroccoliAlso: SulforaphaneBroccoli sprouts extract | Dietary supplement | Broccoli |
| EsomeprazoleEsomeprazole | Drug | Broccoli, Probiotics, Triple Therapy |
| AmoxicillinAmoxicillin | Drug | Broccoli, Probiotics, Triple Therapy |
| ClarithromycinClarithromycin | Drug | Broccoli, Probiotics, Triple Therapy |
Primary outcome
Helicobacter pylori eradication
Time frame: 5 weeks after treatment initiation
Using the urea breath test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
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 Phase 4 study testing Probiotics, Broccoli and Esomeprazole in people with Helicobacter Pylori Infection, run by Kyunghee University Medical Center 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 4 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 4 Jun 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.
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?
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 eradication (time frame: 5 weeks after treatment initiation). 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 4 Jun 2019.