Effect of Gut Microbiota After High-dose Dual Therapy Combined With Probiotics for Helicobacter Pylori Eradication
- Conditions
- Metabolic DisturbanceGut MicrobiotaHelicobacter Pylori Eradication
- Interventions
- Registration Number
- NCT06292546
- Lead Sponsor
- Zhongshan Hospital (Xiamen), Fudan University
- Brief Summary
The aim of this study was to evaluate the effect of gut microbiota after high-dose dual therapy combined with probiotics for Helicobacter pylori eradication
- 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 therapy with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Age from 18 to 65 years;
- H.pylori infection diagnosed by 13C-urea breath test;
- No history of H. pylori eradication.
- Allergy to amoxicillin;
- 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;
- Use of PPI and antibiotics within the previous one month;
- Unwillingness to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Bacillus subtilis enteric-coated capsules 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 C Bacillus subtilis enteric-coated capsules 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 B Bacillus subtilis enteric-coated capsules vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group A Amoxicillin 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 A Vonoprazan 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 vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C Vonoprazan 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 B Amoxicillin vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C Amoxicillin 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 vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D Amoxicillin vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
- Primary Outcome Measures
Name Time Method Gut Microbiota day 0, day 44 (or 58), day 104 (or 118) Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics.
- Secondary Outcome Measures
Name Time Method Fecal Metabolites day 0, day 44 (or 58), day 104 (or 118) Fecal metabolites is tested by Gas Chromatography-Mass Spectrometry Analysis.
Eradication rate day 44 or day 58 Eradication rate of H pylori, presenting with negative results on the 13C-UBT test.
Frequency of the adverse events day 44 or day 58 Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
Compliance rate of the drugs day 44 or day 58 Compliance is defined as good when they had taken more than 80% of the total medication.
Small intestinal bacterial overgrowth day 0, day 44 (or 58), day 104 (or 118) Small intestinal bacterial overgrowth is tested by Hydrogen-Methane Breath.
Trial Locations
- Locations (1)
Zhongshan Hospital (Xiamen), Fudan University
🇨🇳Xiamen, Fujian, China