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

NCT06292546 | Completed

• 1 other identifier: ZYC-Hp2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota; Metabolic Disturbance; Helicobacter Pylori Eradication

Keywords

Helicobacter pylori; Eradication; Vonoprazan; Amoxicillin; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Gut Microbiota

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

  day 0, day 44 (or 58), day 104 (or 118)

Secondary Outcomes (5)

• Fecal Metabolites

  day 0, day 44 (or 58), day 104 (or 118)

• Eradication rate

  day 44 or day 58

• Frequency of the adverse events

  day 44 or day 58

• Compliance rate of the drugs

  day 44 or day 58

• Small intestinal bacterial overgrowth

  day 0, day 44 (or 58), day 104 (or 118)

Study Arms (4)

Group A

EXPERIMENTAL

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.

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules

Group B

EXPERIMENTAL

vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules

Group C

EXPERIMENTAL

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.

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules

Group D

ACTIVE COMPARATOR

vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Drug: Vonoprazan; Drug: Amoxicillin

Interventions

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.

Group A; Group B; Group C; Group D

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.

Group A; Group B; Group C; Group D

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.

Group A; Group B; Group C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University: lead

Study Sites (1)

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

Location

Related Publications (1)

• Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Shu X, Xie Y, Lu NH, Zhu Y. Altered Gut Microbiota and Short-Chain Fatty Acids After Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication. Front Cell Infect Microbiol. 2022 Jun 2;12:881968. doi: 10.3389/fcimb.2022.881968. eCollection 2022.

  PMID: 35719338 RESULT

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yucheng Zhu, Ph.D.

  Zhongshan Hospital (Xiamen), Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: January 31, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)