drugset / Trial / NCT03688828
Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori
Completed
360 enrolled
Huazhong University of Science and Technology
Anlu Puai Hospital · collabCentral Hospital of Xiaogan · collabHubei Aerospace Hospital · collabThe Third People's Hospital of Hubei Province · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWuhan University · collabXiaogan First People's Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2018-11-11
- Primary completion
- 2020-06-10
- Completion
- 2020-12-31
Publications
- Background 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Saccharomyces boulardii | Other / unclassified | 500 mg | — |
| Background | Amoxicillin | Other / unclassified | 1 g | — |
| Background | Bismuth Potassium Citrate | Unknown | 0.22 g | — |
| Background | Clarithromycin | Small molecule | 0.5 g | — |
| Background | Esomeprazole | Small molecule | 20 mg | — |