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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03688828

Enrollment

360

Registered

2018-09-28

Start date

2018-11-11

Completion date

2020-12-31

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Saccharomyces Boulardii, Standard Quadruple Therapy

Brief 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.

Interventions

DRUGSaccharomyces boulardii

500mg bid

DRUGEsomeprazole

20mg bid

DRUGAmoxicillin

1.0g bid

DRUGClarithromycin

0.5g bid

DRUGBismuth potassium citrate

0.22g bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Helicobacter pylori eradication	6 weeks after treatment initiation	to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Secondary

Measure	Time frame	Description
Incidence of adverse events	2 weeks and 4-12 weeks after treatment initiation	to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026