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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Central Hospital of Xiaogan | OTHER |
| Xiaogan First People's Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate |
|
| Quadruple Therapy | Active Comparator | Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii | Drug | 500mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Cheng, Doctor | Tongji Hospital | Principal Investigator |
| Yuchong Zhao, Doctor | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20557362 | 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. | |
| 24834296 | 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. |
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| Hubei Aerospace Hospital |
| UNKNOWN |
| The Third People's Hospital of Hubei Province | OTHER |
| Wuhan University | OTHER |
| Anlu Puai Hospital | UNKNOWN |
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| Esomeprazole | Drug | 20mg bid |
|
| Amoxicillin | Drug | 1.0g bid |
|
| Clarithromycin | Drug | 0.5g bid |
|
| Bismuth potassium citrate | Drug | 0.22g bid |
|
| 21039671 | 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. |
| 34869495 | Derived | 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. |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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