The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment

Zhongshan Hospital (Xiamen), Fudan University

Status: Completed

Conditions: Gut Microbiota; Helicobacter Pylori Eradication; Metabolic Disturbance

Treatments: Drug: Bacillus subtilis enteric-coated capsules; Drug: Vonoprazan; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06292546

ZYC-Hp2024

Details and patient eligibility

About

The aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment.

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 65 years;
• H.pylori infection diagnosed by 13C-urea breath test;
• A period of more than two months since the last eradication therapy for H. pylori;
• Patients who had previously failed 2 or more eradication regimens.

Exclusion criteria

• Allergy to any of the medications;
• 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;
• Patients who had used probiotics, vonoprazan, and antibiotics in the past 12 weeks;
• Unwillingness to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Group A

Experimental group

Description:

vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Bacillus subtilis enteric-coated capsules

Group B

Experimental group

Description:

vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Bacillus subtilis enteric-coated capsules

Group C

Experimental group

Description:

2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

Drug: Bacillus subtilis enteric-coated capsules

Group D

Active Comparator group

Description:

vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan