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

May 31, 2019 updated by: Jung-Wook Kim, Kyunghee University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Drug: Esomeprazole
Esomeprazole
Drug: Amoxicillin
Amoxicillin
Drug: Clarithromycin
Clarithromycin
Dietary supplement: Broccoli
Broccoli sprouts extract
Other Names:
  • Sulforaphane
Active Comparator: Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
Drug: Esomeprazole
Esomeprazole
Drug: Amoxicillin
Amoxicillin
Drug: Clarithromycin
Clarithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication
Time Frame: 5 weeks after treatment initiation
Using the urea breath test
5 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

July 9, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Broccoli2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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