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

Sponsor
Kyunghee University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03220542
Collaborator
(none)
360
Enrollment
1
Location
3
Arms
48
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotics

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

Drug: Probiotics
Saccharomyces boulardii
Other Names:
  • 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 Names:
  • 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

    Primary Outcome Measures

    1. Helicobacter pylori eradication [5 weeks after treatment initiation]

      Using the urea breath test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyung Hee University Hospital Seoul Korea, Republic of 130-872

    Sponsors and Collaborators

    • Kyunghee University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Wook Kim, Clinical assistant professor, Kyunghee University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03220542
    Other Study ID Numbers:
    • Broccoli2014
    First Posted:
    Jul 18, 2017
    Last Update Posted:
    Jun 4, 2019
    Last Verified:
    May 1, 2019
    Keywords provided by Jung-Wook Kim, Clinical assistant professor, Kyunghee University Medical Center
    Helicobacter Pylori
    Probiotics
    Sulforaphane
    Additional relevant MeSH terms:
    Amoxicillin
    Clarithromycin
    Sulforaphane
    Esomeprazole

    Study Results

    No Results Posted as of Jun 4, 2019