The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

NCT05658055 | Unknown Phase 4

• 1 other identifier: KY20221124-08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infection; Infections; Intestinal Bacteria Flora Disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Helicobacter pylori eradication rate

  four to six weeks after completion of the medication

• Adverse event

  one week after completion of the medication

Study Arms (2)

Amoxicillin combined with vonoprazan

ACTIVE COMPARATOR

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: Vonoprazan; Drug: Amoxicillin

Probiotics combined with vonoprazan and amoxicillin

EXPERIMENTAL

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: Vonoprazan; Drug: Amoxicillin; Drug: probiotics

Interventions

Vonoprazan DRUG

Potassium-competitive acid blocker

Amoxicillin combined with vonoprazan; Probiotics combined with vonoprazan and amoxicillin

Amoxicillin DRUG

Antibiotic for H. pylori eradication

Amoxicillin combined with vonoprazan; Probiotics combined with vonoprazan and amoxicillin

probiotics DRUG

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

Probiotics combined with vonoprazan and amoxicillin

Eligibility Criteria

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

You may qualify if:

• Ages between 18 and 65 years; Sexes eligible for study: both;
• patients who are diagnosed with Helicobacter pylori;
• 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;
• voluntary to be involved in the study and written informed consent was obtained from all patients

You may not qualify if:

• allergic reactions to the study drugs;
• patients with peptic ulcer;
• patients who underwent eradication therapy for Helicobacter pylori during the last six months;
• 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;
• patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
• patients who have history of esophageal or gastric surgery;
• pregnant or lactating women;
• patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
• Alcohol abusers

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Infections

Interventions

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

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; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zhenyu Zhang

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Zhenyu Zhang

CONTACT

+86 025-87726248; zzy6565@sina.com

Yunfan Dong

CONTACT

+86 18795993220; dyf967878@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 20, 2022
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)