NCT06292546

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

The Effects of High-dose Dual Therapy Combined With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Zhongshan Hospital (Xiamen), Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Gut Microbiota
• Metabolic Disturbance
• Helicobacter Pylori Eradication

Interventions

Type	Name	Description
DRUG	Vonoprazan	Group A: 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. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 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. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
DRUG	Amoxicillin	Group A: 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. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 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. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
DRUG	Bacillus subtilis enteric-coated capsules	Group A: 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. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 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. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-12-30
• Completion: 2025-02-28
• First posted: 2024-03-05
• Last updated: 2025-05-13

Locations

1 site across 1 country: China