The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJune 4, 2019
May 1, 2019
3 years
July 9, 2017
May 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori eradication
Using the urea breath test
5 weeks after treatment initiation
Study Arms (3)
Probiotics
EXPERIMENTALSaccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
Broccoli
EXPERIMENTALBroccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
Triple Therapy
ACTIVE COMPARATOREsomeprazole + Amoxicillin + Clarithromycin
Interventions
Saccharomyces boulardii
Eligibility Criteria
You may qualify if:
- Helicobacter pylori infected patients
- Patients with active or healing gastric/duodenal ulcers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Hospital
Seoul, 130-872, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
July 9, 2017
First Posted
July 18, 2017
Study Start
January 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
June 4, 2019
Record last verified: 2019-05