Clinical trial NCT03688828: Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori
Official title: The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Saccharomyces Boulardii
Standard Quadruple Therapy
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Central Hospital of Xiaogan
name: Xiaogan First People's Hospital
name: Hubei Aerospace Hospital
name: The Third People's Hospital of Hubei Province
name: Wuhan University
name: Anlu Puai Hospital
First posted: 2018-09-28
Enrollment: 360
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Helicobacter pylori eradication
timeFrame: 6 weeks after treatment initiation
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 2 weeks and 4-12 weeks after treatment initiation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Bin Cheng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Yuchong Zhao, Doctor
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
citation: 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.