NCT03688828

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

The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Saccharomyces boulardii	500mg bid
DRUG	Esomeprazole	20mg bid
DRUG	Amoxicillin	1.0g bid
DRUG	Clarithromycin	0.5g bid
DRUG	Bismuth potassium citrate	0.22g bid

Timeline

• Start date: 2018-11-11
• Primary completion: 2020-06-10
• Completion: 2020-12-31
• First posted: 2018-09-28
• Last updated: 2021-10-26

Locations

1 site across 1 country: China