Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection

NCT07012785 | Not Yet Recruiting

• 1 other identifier: 2025ZDSYLL071-P01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. Pylori eradication rate

  7 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Drug: Bismuth quadruple therapy

Experimental group

EXPERIMENTAL

Drug: Saccharomyces boulardii

Interventions

Bismuth quadruple therapy DRUG

Bismuth quadruple therapy

Control Group

Saccharomyces boulardii DRUG

Saccharomyces boulardii

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years, regardless of gender;
• Positive 13C/14C urea breath test result;
• No previous history of H. pylori eradication treatment;
• Agreement to participate in this study and signing of the informed consent form.

You may not qualify if:

• History of ≥ 1 instance of failed H. pylori eradication;
• Use of antibiotics (including antibacterial traditional Chinese medicines), nonsteroidal anti-inflammatory drugs (NSAIDS), bismuth agents, H2 receptor antagonists (H2RAs), proton-pump inhibitors (PPIs), and potassium-competitive acid blockers (P-CAB) within 4 weeks before treatment;
• Plans to conceive, pregnancy, or breastfeeding;
• Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
• Allergies to the drugs used in this study or a history of penicillin allergy;
• The inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

Central Study Contacts

Lu Chen

CONTACT

13611569073; 13611569073@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CN (1)