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

Kyung Hee University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Dietary Supplement: Broccoli; Drug: Probiotics; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03220542

Broccoli2014

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Probiotics

Experimental group

Description:

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

Treatment:

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin

Drug: Probiotics

Broccoli

Experimental group

Description:

Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin

Treatment:

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin

Dietary Supplement: Broccoli

Triple Therapy

Active Comparator group

Description:

Esomeprazole + Amoxicillin + Clarithromycin

Treatment:

Drug: Amoxicillin

Drug: Esomeprazole

Drug: Clarithromycin