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

Huazhong University of Science and Technology

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Bismuth potassium citrate; Drug: Esomeprazole; Drug: Saccharomyces boulardii; Drug: Amoxicillin; Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03688828

BoulardiitoHp2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 360 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 2 patient groups

Probiotics

Experimental group

Description:

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate

Treatment:

Drug: Amoxicillin

Drug: Bismuth potassium citrate

Drug: Clarithromycin

Drug: Esomeprazole

Drug: Saccharomyces boulardii

Quadruple Therapy

Active Comparator group

Description:

Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate

Treatment:

Drug: Amoxicillin

Drug: Bismuth potassium citrate

Drug: Clarithromycin

Drug: Esomeprazole