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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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Probiotics

Saccharomyces boulardii

Intervention Type DRUG

Broccoli

Broccoli sprouts extract

Intervention Type DIETARY_SUPPLEMENT

Esomeprazole

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Other Intervention Names

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Bioflor 250, Kuhnil Pharmacy, Seoul, Korea Sulforaphane

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No