The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
NCT Number: NCT05191875
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410013, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Saccharomyces Boulardii:
0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory
Other names: treatment drugs of stage I
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
Other names: treatment drugs of stage II
Time frame: Visit period 2 (day 42±3)
Evaluated by 13C-urea breath test (13C-UBT), or 14C-urea breath test (14C-UBT).
Time frame: Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Follow-up of patients' adverse reactions by telephone and at the gastroenterology clinic
The Third Xiangya Hospital of Central South University
Other
Gastrointestinal Preparation and Efficacy of Saccharomyces Boulardii as a Pre-treatment for Helicobacter Pylori Rescue Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06561711
Helicobacter Pylori Infection, cyclopia sequence
Beijing, Beijing Municipality, China
View Trial DetailsNCT07122284
Gut Microbiota, Helicobacter Pylori Infection
Xiamen, Fujian, China
View Trial DetailsNCT06340334
Furazolidone, Helicobacter Pylori Infection
Nanjing, China
View Trial DetailsNCT06412588
Helicobacter Pylori Infection
Nanjing, Jiangsu, China
View Trial Details