Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori

NCT ID: NCT05191875

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-04-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1 of stage I

14-day therapy：Saccharomyces boulardii. 500mg b.i.d

Group Type: EXPERIMENTAL

Saccharomyces Boulardii 250 MG

Intervention Type: DRUG

Saccharomyces Boulardii:

0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory

group 2 of stage I

Observe for one month before treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

stage 2

14-day therapy：Ilaprazole. 5mg b.i.d Doxycycline. 0.1g b.i.d Furazolidone. 0.1g b.i.d Colloidal Bismuth Tartrate . 220mg b.i.d

Group Type: OTHER

Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate

Intervention Type: DRUG

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

Interventions

Saccharomyces Boulardii 250 MG

Saccharomyces Boulardii:

0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

treatment drugs of stage I; treatment drugs of stage II

Eligibility Criteria

Inclusion Criteria

1. aged 18 to 65 years, of either sex

2. patients with a diagnosis of Hp infection

3. patients who have failed treatment for Hp infection

4. not taking acid-suppressing medications (PPI or H2 blockers) within the last 2 weeks

5. who have not used antibiotics and/or bismuth within the last 4 weeks

6. understand and are willing to participate in this clinical trial and provide a signed informed consent form.

Exclusion Criteria

1. those with a history of drug allergy

2. those with severe cardiac, hepatic, pulmonary, and renal insufficiencies

3. those with a recent history of gastrointestinal hemorrhage, obstruction, perforation, tumors, and other serious organic diseases of the gastrointestinal tract

4. those with mental illness, psychological disorders that cannot be expressed normally

5. those who are pregnant, lactating, or planning to have children in the near future during the study period.

6. those who are not suitable for clinical trials and those who cannot cooperate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

xucanxia

Identifier Type: -

Identifier Source: org_study_id