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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Saccharomyces Boulardii 250 MG; Drug: Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1 of stage I; 14-day therapy：Saccharomyces boulardii. 500mg b.i.d	Drug: Saccharomyces Boulardii 250 MG; Saccharomyces Boulardii: 0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory; Other Names: treatment drugs of stage I
No Intervention: group 2 of stage I; Observe for one month before treatment
Other: 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	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; Other Names: treatment drugs of stage II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The eradication rate of H. pylori infection	Evaluated by 13C-urea breath test (13C-UBT), or 14C-urea breath test (14C-UBT).	Visit period 2 (day 42±3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Follow-up of patients' adverse reactions by telephone and at the gastroenterology clinic	Visit period 1 (day 14±1), Visit period 2 (day 28±1)

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 23, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Saccharomyces boulardii Helicobacter pylori rescue
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Antimalarials; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Doxycycline; Bismuth; Furazolidone
• Other Study ID Numbers: xucanxia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No