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

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Dietary Supplement: Broccoli; Drug: Probiotics; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin

• Registration Number: NCT03220542
• Lead Sponsor: Kyunghee University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-18
• Primary Completion: 2018-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-04
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Broccoli	Broccoli	Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
Probiotics	Probiotics	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
Probiotics	Esomeprazole	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
Broccoli	Esomeprazole	Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
Probiotics	Clarithromycin	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
Probiotics	Amoxicillin	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
Broccoli	Amoxicillin	Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
Broccoli	Clarithromycin	Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
Triple Therapy	Esomeprazole	Esomeprazole + Amoxicillin + Clarithromycin
Triple Therapy	Amoxicillin	Esomeprazole + Amoxicillin + Clarithromycin
Triple Therapy	Clarithromycin	Esomeprazole + Amoxicillin + Clarithromycin

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	5 weeks after treatment initiation	Using the urea breath test

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of