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NCT03220542 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03220542
Other study ID # Broccoli2014
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 2016
Est. completion date December 31, 2019

Study information
Verified date May 2019
Source Kyunghee University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 360
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Probiotics
Saccharomyces boulardii
Dietary Supplement:
• Broccoli
Broccoli sprouts extract
Drug:
• Esomeprazole
Esomeprazole
• Amoxicillin
Amoxicillin
• Clarithromycin
Clarithromycin

Locations
Country Name City State
Korea, Republic of Kyung Hee University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Helicobacter pylori eradication Using the urea breath test 5 weeks after treatment initiation
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