The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial

The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics

Study Overview

• Status: Not yet recruiting
• Conditions: Infections; Helicobacter Pylori Infection; Intestinal Bacteria Flora Disturbance
• Intervention / Treatment: Drug: Amoxicillin; Drug: Vonoprazan; Drug: probiotics

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing First Hospital, Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages between 18 and 65 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Amoxicillin combined with vonoprazan; The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Vonoprazan; Potassium-competitive acid blocker
EXPERIMENTAL: Probiotics combined with vonoprazan and amoxicillin; The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days.	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Vonoprazan; Potassium-competitive acid blocker; Drug: probiotics; Medilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The comparison of the gut microbiota composition	Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.	12mouth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.	four to six weeks after completion of the medication
Adverse event	adverse events are recorded by the patient	one week after completion of the medication

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (ACTUAL): December 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: KY20221124-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No