The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection Infections Intestinal Bacteria Flora Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

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.

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

probiotics

Intervention Type DRUG

Medilac-S; Enterococcus faecium 4.5\*10\^8 and Bacillus subtilis 5.0\*10\^7, Hanmi,Beijing, China

Interventions

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Vonoprazan

Potassium-competitive acid blocker

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

probiotics

Medilac-S; Enterococcus faecium 4.5\*10\^8 and Bacillus subtilis 5.0\*10\^7, Hanmi,Beijing, China

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No