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

NCT ID: NCT03688828

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-11

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotics

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

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DRUG

500mg bid

Esomeprazole

Intervention Type DRUG

20mg bid

Amoxicillin

Intervention Type DRUG

1.0g bid

Clarithromycin

Intervention Type DRUG

0.5g bid

Bismuth potassium citrate

Intervention Type DRUG

0.22g bid

Quadruple Therapy

Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

20mg bid

Amoxicillin

Intervention Type DRUG

1.0g bid

Clarithromycin

Intervention Type DRUG

0.5g bid

Bismuth potassium citrate

Intervention Type DRUG

0.22g bid

Interventions

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Saccharomyces boulardii

500mg bid

Intervention Type DRUG

Esomeprazole

20mg bid

Intervention Type DRUG

Amoxicillin

1.0g bid

Intervention Type DRUG

Clarithromycin

0.5g bid

Intervention Type DRUG

Bismuth potassium citrate

0.22g bid

Intervention Type DRUG

Other Intervention Names

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Brad's yeast powder;Biocodex, Paris, France

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Central Hospital of Xiaogan

OTHER

Sponsor Role collaborator

Xiaogan First People's Hospital

UNKNOWN

Sponsor Role collaborator

Hubei Aerospace Hospital

UNKNOWN

Sponsor Role collaborator

The Third People's Hospital of Hubei Province

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Anlu Puai Hospital

UNKNOWN

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Bin Cheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Cheng, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Yuchong Zhao, Doctor

Role: STUDY_CHAIR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Song MJ, Park DI, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. The effect of probiotics and mucoprotective agents on PPI-based triple therapy for eradication of Helicobacter pylori. Helicobacter. 2010 Jun;15(3):206-13. doi: 10.1111/j.1523-5378.2010.00751.x.

Reference Type BACKGROUND
PMID: 20557362 (View on PubMed)

Zojaji H, Ghobakhlou M, Rajabalinia H, Ataei E, Jahani Sherafat S, Moghimi-Dehkordi B, Bahreiny R. The efficacy and safety of adding the probiotic Saccharomyces boulardiito standard triple therapy for eradication of H.pylori: a randomized controlled trial. Gastroenterol Hepatol Bed Bench. 2013;6(Suppl 1):S99-S104.

Reference Type BACKGROUND
PMID: 24834296 (View on PubMed)

Szajewska H, Horvath A, Piwowarczyk A. Meta-analysis: the effects of Saccharomyces boulardii supplementation on Helicobacter pylori eradication rates and side effects during treatment. Aliment Pharmacol Ther. 2010 Nov;32(9):1069-79. doi: 10.1111/j.1365-2036.2010.04457.x. Epub 2010 Sep 16.

Reference Type BACKGROUND
PMID: 21039671 (View on PubMed)

Zhao Y, Yang Y, Aruna, Xiao J, Song J, Huang T, Li S, Kou J, Huang L, Ji D, Xiong S, Peng W, Xu S, Cheng B. Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial. Front Med (Lausanne). 2021 Nov 18;8:776955. doi: 10.3389/fmed.2021.776955. eCollection 2021.

Reference Type DERIVED
PMID: 34869495 (View on PubMed)

Other Identifiers

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BoulardiitoHp2018

Identifier Type: -

Identifier Source: org_study_id