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

NCT03688828 | Completed

• 1 other identifier: BoulardiitoHp2018
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Saccharomyces Boulardii; Standard Quadruple Therapy

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

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

  6 weeks after treatment initiation

Secondary Outcomes (1)

• Incidence of adverse events

  2 weeks and 4-12 weeks after treatment initiation

Study Arms (2)

Probiotics

EXPERIMENTAL

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

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

Quadruple Therapy

ACTIVE COMPARATOR

Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate

Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth potassium citrate

Interventions

Saccharomyces boulardii DRUG

500mg bid

Also known as: Brad's yeast powder;Biocodex, Paris, France

Probiotics

Esomeprazole DRUG

20mg bid

Probiotics; Quadruple Therapy

Amoxicillin DRUG

1.0g bid

Probiotics; Quadruple Therapy

Clarithromycin DRUG

0.5g bid

Probiotics; Quadruple Therapy

Bismuth potassium citrate DRUG

0.22g bid

Probiotics; Quadruple Therapy

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Helicobacter pylori infected patients
• C DOB\>8
• age 22\~65

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Central Hospital of Xiaogan: collaborator
• Xiaogan First People's Hospital: collaborator
• Hubei Aerospace Hospital: collaborator
• The Third People's Hospital of Hubei Province: collaborator
• Wuhan University: collaborator
• Anlu Puai Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (4)

• 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.

  PMID: 20557362 BACKGROUND

• 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.

  PMID: 24834296 BACKGROUND

• 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.

  PMID: 21039671 BACKGROUND

• 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.

  PMID: 34869495 DERIVED

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Bin Cheng, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Yuchong Zhao, Doctor

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: November 11, 2018
• Primary Completion: June 10, 2020
• Study Completion: December 31, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

CN (1)