- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220542
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
-
-
-
Seoul, Korea, Republic of, 130-872
- Kyung Hee University Hospital
-
-
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
|
Saccharomyces boulardii
Other Names:
Esomeprazole
Amoxicillin
Clarithromycin
|
Experimental: Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
|
Esomeprazole
Amoxicillin
Clarithromycin
Broccoli sprouts extract
Other Names:
|
Active Comparator: Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
|
Esomeprazole
Amoxicillin
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.
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Protective Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Anticarcinogenic Agents
- Amoxicillin
- Clarithromycin
- Esomeprazole
- Sulforaphane
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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