The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment

Last updated: May 10, 2025
Sponsor: Zhongshan Hospital (Xiamen), Fudan University
Overall Status: Completed

Phase

N/A

Condition

Helicobacter Pylori

Treatment

Vonoprazan

Amoxicillin

vonoprazan

Clinical Study ID

NCT06292546
ZYC-Hp2024
  • Ages 18-65
  • All Genders

Study Summary

The aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 18 to 65 years;

  • H.pylori infection diagnosed by 13C-urea breath test;

  • A period of more than two months since the last eradication therapy for H. pylori;

  • Patients who had previously failed 2 or more eradication regimens.

Exclusion

Exclusion Criteria:

  • Allergy to any of the medications;

  • Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active pepticulcer;

  • Coexistence of significant concomitant illnesses, including heart disease, renalfailure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;

  • Patients who had used probiotics, vonoprazan, and antibiotics in the past 12 weeks;

  • Unwillingness to participate in this study.

Study Design

Total Participants: 72
Treatment Group(s): 5
Primary Treatment: Vonoprazan
Phase:
Study Start date:
January 31, 2024
Estimated Completion Date:
February 28, 2025

Study Description

The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve notable eradication rates for Helicobacter pylori (H. pylori). Patients who receive this treatment are prone to adverse reactions, such as diarrhea, abdominal distention. We plan to combine probiotic with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.

Connect with a study center

  • Zhongshan Hospital (Xiamen), Fudan University

    Xiamen, Fujian 361015
    China

    Site Not Available

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