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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03220542

Recruitment Status : Unknown

Verified May 2019 by Jung-Wook Kim, Kyunghee University Medical Center.
Recruitment status was: Active, not recruiting

First Posted : July 18, 2017

Last Update Posted : June 4, 2019

Sponsor:

Information provided by (Responsible Party):

Jung-Wook Kim, Kyunghee University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: Probiotics Dietary Supplement: Broccoli Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial
Actual Study Start Date :	January 2016
Actual Primary Completion Date :	December 31, 2018
Estimated Study Completion Date :	December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Probiotics Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin	Drug: Probiotics Saccharomyces boulardii Other Name: Bioflor 250, Kuhnil Pharmacy, Seoul, Korea Drug: Esomeprazole Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin
Experimental: Broccoli Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin	Dietary Supplement: Broccoli Broccoli sprouts extract Other Name: Sulforaphane Drug: Esomeprazole Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin
Active Comparator: Triple Therapy Esomeprazole + Amoxicillin + Clarithromycin	Drug: Esomeprazole Esomeprazole Drug: Amoxicillin Amoxicillin Drug: Clarithromycin Clarithromycin

Outcome Measures

Primary Outcome Measures :

Helicobacter pylori eradication [ Time Frame: 5 weeks after treatment initiation ]
Using the urea breath test

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220542

Locations

Layout table for location information

Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872

Sponsors and Collaborators

Kyunghee University Medical Center

More Information

Layout table for additonal information

Responsible Party:	Jung-Wook Kim, Clinical assistant professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:	NCT03220542
Other Study ID Numbers:	Broccoli2014
First Posted:	July 18, 2017 Key Record Dates
Last Update Posted:	June 4, 2019
Last Verified:	May 2019

Keywords provided by Jung-Wook Kim, Kyunghee University Medical Center:


Helicobacter Pylori Probiotics Sulforaphane

Additional relevant MeSH terms:

Layout table for MeSH terms

Amoxicillin Clarithromycin Sulforafan Esomeprazole Anti-Bacterial Agents Anti-Infective Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents

To Top