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Completed

NCT Number: NCT06292546

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

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.

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Key information

Conditions

Gut Microbiota Helicobacter Pylori Eradication Metabolic Disturbance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • Allergy to any of the medications;
  • Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active peptic ulcer;
  • Coexistence of significant concomitant illnesses, including heart disease, renal failure, 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.

Treatment and study plan

Vonoprazan

Drug

Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Amoxicillin

Drug

Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Bacillus subtilis enteric-coated capsules

Drug

Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Primary outcomes

  1. Gut Microbiota

    Time frame: day 0, day 44 (or 58), day 104 (or 118)

    Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics.

Secondary outcomes

  1. Fecal Metabolites

    Time frame: day 0, day 44 (or 58), day 104 (or 118)

    Fecal metabolites is tested by Gas Chromatography-Mass Spectrometry Analysis.

  2. Eradication rate

    Time frame: day 44 or day 58

    Eradication rate of H pylori, presenting with negative results on the 13C-UBT test.

  3. Frequency of the adverse events

    Time frame: day 44 or day 58

    Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.

  4. Compliance rate of the drugs

    Time frame: day 44 or day 58

    Compliance is defined as good when they had taken more than 80% of the total medication.

  5. Small intestinal bacterial overgrowth

    Time frame: day 0, day 44 (or 58), day 104 (or 118)

    Small intestinal bacterial overgrowth is tested by Hydrogen-Methane Breath.

Sponsors and collaborators

Lead sponsor

Zhongshan Hospital (Xiamen), Fudan University

Other

Registry information

Official study title

The Effects of High-dose Dual Therapy Combined With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
May 13, 2025

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.

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