Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

Huazhong University of Science and Technology360 enrolled

Overview

The eradication rate of standard quadruple therapy 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. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therap.

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. 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. Several studies previously suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events with PPI-based triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with triple therapy. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

360

Conditions

Helicobacter Pylori Infection

Interventions

Saccharomyces boulardiiDRUG

500mg bid

EsomeprazoleDRUG

20mg bid

AmoxicillinDRUG

1.0g bid

Clarithromycin

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Helicobacter pylori infected patients * 13C DOB\>8 * age 22\~65 Exclusion Criteria: * prior Hp eradication therapy including amoxicillin and clarithromycin * previous gastric resection * allergic to the drugs used in this study * previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study * Patients who were pregnant or lactating * Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy，diabete mellitus, hypertension…) effect the evaluation of this study * Can't express the complaint correctly

Locations (1)

Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Helicobacter pylori eradication

to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Time frame: 6 weeks after treatment initiation

Secondary Outcomes

Incidence of adverse events

to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events

Time frame: 2 weeks and 4-12 weeks after treatment initiation

Data from ClinicalTrials.gov

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