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

Study Overview
=================
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.

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

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Probiotics
* Dietary Supplement: Broccoli
* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin | Drug: Probiotics<br>* Saccharomyces boulardii<br>* Other names: Bioflor 250, Kuhnil Pharmacy, Seoul, Korea;Drug: Esomeprazole<br>* Esomeprazole<br>Drug: Amoxicillin<br>* Amoxicillin<br>Drug: Clarithromycin<br>* Clarithromycin<br>|
| Experimental: Broccoli<br>Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin | Dietary Supplement: Broccoli<br>* Broccoli sprouts extract<br>* Other names: Sulforaphane;Drug: Esomeprazole<br>* Esomeprazole<br>Drug: Amoxicillin<br>* Amoxicillin<br>Drug: Clarithromycin<br>* Clarithromycin<br>|
| Active Comparator: Triple Therapy<br>Esomeprazole + Amoxicillin + Clarithromycin | Drug: Esomeprazole<br>* Esomeprazole<br>Drug: Amoxicillin<br>* Amoxicillin<br>Drug: Clarithromycin<br>* Clarithromycin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication | Using the urea breath test | 5 weeks after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter Pylori, Probiotics, Sulforaphane