NCT05658055

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Helicobacter Pylori Infection
• Infections
• Intestinal Bacteria Flora Disturbance

Interventions

Type	Name	Description
DRUG	Vonoprazan	Potassium-competitive acid blocker
DRUG	Amoxicillin	Antibiotic for H. pylori eradication
DRUG	probiotics	Medilac-S; Enterococcus faecium 4.5\*10\^8 and Bacillus subtilis 5.0\*10\^7, Hanmi,Beijing, China

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-12-20
• Last updated: 2023-02-08

Locations

1 site across 1 country: China