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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688828
• Other study ID #: BoulardiitoHp2018
• Status: Completed
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 31, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Saccharomyces boulardii
500mg bid
• Esomeprazole
20mg bid
• Amoxicillin
1.0g bid
• Clarithromycin
0.5g bid
• Bismuth potassium citrate
0.22g bid

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (8)

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

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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