The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori
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ClinicalTrials.gov Identifier: NCT03220542 |
Recruitment Status : Unknown
Verified May 2019 by Jung-Wook Kim, Kyunghee University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : June 4, 2019
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Condition or disease | Intervention/treatment | Phase |
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Helicobacter Pylori Infection | Drug: Probiotics Dietary Supplement: Broccoli Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 2016 |
Actual Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Experimental: Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
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Drug: Probiotics
Saccharomyces boulardii
Other Name: Bioflor 250, Kuhnil Pharmacy, Seoul, Korea Drug: Esomeprazole Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin |
Experimental: Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
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Dietary Supplement: Broccoli
Broccoli sprouts extract
Other Name: Sulforaphane Drug: Esomeprazole Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin |
Active Comparator: Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
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Drug: Esomeprazole
Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin |
- Helicobacter pylori eradication [ Time Frame: 5 weeks after treatment initiation ]Using the urea breath test

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Helicobacter pylori infected patients
- Patients with active or healing gastric/duodenal ulcers
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220542
Korea, Republic of | |
Kyung Hee University Hospital | |
Seoul, Korea, Republic of, 130-872 |
Responsible Party: | Jung-Wook Kim, Clinical assistant professor, Kyunghee University Medical Center |
ClinicalTrials.gov Identifier: | NCT03220542 |
Other Study ID Numbers: |
Broccoli2014 |
First Posted: | July 18, 2017 Key Record Dates |
Last Update Posted: | June 4, 2019 |
Last Verified: | May 2019 |
Helicobacter Pylori Probiotics Sulforaphane |
Amoxicillin Clarithromycin Sulforaphane Esomeprazole Anti-Bacterial Agents Anti-Infective Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents |