Effect of Intestinal Microecology After HDDT Combined With Probiotics for Helicobacter Pylori Eradication

March 6, 2024 updated by: Zhongshan Hospital (Xiamen), Fudan University

Effect of Intestinal Microecology After High Dose Dual Therapy Combined With Probiotics for Helicobacter Pylori Eradication: a Randomized Controlled Trial

The aim of this study was to evaluate the effect of Intestinal microecology after high dose dual therapy combined with probiotics for Helicobacter pylori eradication

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 therapy with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age from 18 to 65 years;
  • H.pylori infection diagnosed by 13C-urea breath test;
  • no history of H. pylori eradication.

Exclusion Criteria:

  • allergy to amoxicillin;
  • 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;
  • use of PPI and antibiotics within the previous one month;
  • unwillingness to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Vonorason 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: Vonorason
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Amoxicillin
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Bacillus subtilis enteric-coated capsules
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Experimental: Group B
Vonorason 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
Drug: Vonorason
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Amoxicillin
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Bacillus subtilis enteric-coated capsules
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Experimental: Group C
2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Vonorason
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Amoxicillin
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Bacillus subtilis enteric-coated capsules
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Active Comparator: Group D
Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Vonorason
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Drug: Amoxicillin
Group A: Vonorason 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: Vonorason 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 vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: Vonorason 20 mg bid + amoxicillin 0.75 g qid for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiota
Time Frame: 44 days
Diversity and Compositional Analysis of Gut Microbiota is tested by DNA Extraction and 16S rRNA Gene Amplification.
44 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal metabolites
Time Frame: 44 days
Diversity and Compositional Analysis of Fecal metabolites is tested by Purification and Gas Chromatography-Mass Spectrometry Analysis of Short-Chain Fatty Acids.
44 days
Eradication rate
Time Frame: 44 days
Eradication rate of H pylori, presenting with negative results on the 13C-UBT test
44 days
Frequency of the adverse events
Time Frame: 44 days
Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
44 days
Compliance rate of the drugs
Time Frame: 44 days
Compliance is defined as good when they had taken more than 80% of the total medication.
44 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Hospital (Xiamen), Fudan University

Investigators

  • Principal Investigator: Yucheng Zhu, Ph.D., Zhongshan Hospital (Xiamen), Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYC-Hp2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.

IPD Sharing Time Frame

The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.

IPD Sharing Access Criteria

Emails could be sent to the emails below to obtain the shared data: zhu.xiaosan@zsxmhospital.com; li.keng@zsxmhospital.com;

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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