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The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03220542
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jung-Wook Kim, Kyunghee University Medical Center

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Probiotics Dietary Supplement: Broccoli Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin Phase 4

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
 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
 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
 Drug: Esomeprazole
Esomeprazole

Drug: Amoxicillin
Amoxicillin

Drug: Clarithromycin
Clarithromycin


Outcome Measures
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Primary Outcome Measures :
  1. Helicobacter pylori eradication [ Time Frame: 5 weeks after treatment initiation ]
    Using the urea breath test


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
Kyunghee University Medical Center
More Information
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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
Keywords provided by Jung-Wook Kim, Kyunghee University Medical Center:
Helicobacter Pylori
Probiotics
Sulforaphane
Additional relevant MeSH terms:
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Amoxicillin
Clarithromycin
Sulforafan
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