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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03688828
• Collaborator: Wuhan Union Hospital, China (Other), Xiaogan Central Hospital (Other), Xiaogan First People's Hospital (Other), Hubei Aerospace Hospital (Other), The third people's Hospital of Hubei Province (Other), Wuhan University (Other), Anlu Puai Hospital (Other)
• Enrollment: 360
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.7
• Patients Per Site Per Month: 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Saccharomyces boulardii; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth potassium citrate	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial
• Actual Study Start Date: Nov 11, 2018
• Actual Primary Completion Date: Jun 10, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotics Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate	Drug: Saccharomyces boulardii; 500mg bid; Other Names: Brad's yeast powder;Biocodex, Paris, France ; Drug: Esomeprazole; 20mg bid; Drug: Amoxicillin; 1.0g bid; Drug: Clarithromycin; 0.5g bid; Drug: Bismuth potassium citrate; 0.22g bid
Active Comparator: Quadruple Therapy Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate	Drug: Esomeprazole; 20mg bid; Drug: Amoxicillin; 1.0g bid; Drug: Clarithromycin; 0.5g bid; Drug: Bismuth potassium citrate; 0.22g bid

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Huazhong University of Science and Technology
• Wuhan Union Hospital, China
• Xiaogan Central Hospital
• Xiaogan First People's Hospital
• Hubei Aerospace Hospital
• The third people's Hospital of Hubei Province
• Wuhan University
• Anlu Puai Hospital

Investigators

• Principal Investigator: Bin Cheng, Doctor, Tongji Hospital
• Study Chair: Yuchong Zhao, Doctor, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Erratum in: Aliment Pharmacol Ther. 2010 Dec;32(11-12):1408.
• 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.

• Responsible Party: Bin Cheng, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03688828
• Other Study ID Numbers: BoulardiitoHp2018
• First Posted: Sep 28, 2018
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bin Cheng, Professor, Tongji Hospital: Saccharomyces Boulardii; Standard Quadruple Therapy
• Additional relevant MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Esomeprazole; Bismuth

Study Results

No Results Posted as of Oct 26, 2021