NCT05191875

Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori

Gastrointestinal Preparation and Efficacy of Saccharomyces Boulardii as a Pre-treatment for Helicobacter Pylori Rescue Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori) with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the eradication rate, and the secondary outcome was the incidence of adverse events.

Detailed description

Background: Helicobacter pylori(H.pylori)infection is a common bacterial infection that causes chronic gastritis, peptic ulcer, MALT lymphoma, gastric cancer, and other gastrointestinal diseases. and has been classified as a group 1 biologic carcinogen with a prevalence of about 50% population in china. In recent years, with the massive use of antibiotics, poor patient compliance, and irregular drug use, the side effects associated with drugs have increased and have led to the development of antibiotic-resistant bacteria and a gradual increase in refractory H.pylori infections, researchers have been searching for a safe, effective and simple treatment for H. pylori. Methods: The patient come from the department of Gastroenterology, Xiangya Third Hospital, Central South University. After obtaining informed consent, patients is randomly divided into a study group and a control group. The study group (n=100) is divided into two stages of treatment, starting with Saccharomyces boulardii monnotherapy for 14 days, Patients who are still positive on reexamination after 4 weeks of stopping the drug continue with bismuth quadruple therapy. As for the control group (n=100), patients is observed for 4 weeks without any gastric drugs as well as antibiotics, and those who were still positive on retest after 4 weeks continued with bismuth quadruple therapy. We observe the eradication rate of patients and the occurrence of adverse effects during the treatment.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Saccharomyces Boulardii 250 MG	Saccharomyces Boulardii: 0.25 g \* 6, Produced by The French encyclopedia pharmaceutical Factory
DRUG	Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate	Ilaprazole: 5mg\*6, produced by Livzon Pharmaceutical Group Inc Doxycycline: 0.1 g \* 10, produced by Jiangsu Yongxin Ltd. Furazolidone: 0.1g\*100 produced by Tianjin Lisheng Pharmaceutical Co., LTD Colloidal Bismuth Tartrate: 55 mg \* 36,produced by Shanxi Xinbaoyuan Pharmaceutical Co., LTD

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-04-12
• Completion: 2022-04-23
• First posted: 2022-01-14
• Last updated: 2022-05-24

Locations

1 site across 1 country: China