Gut Microbiota, Helicobacter Pylori Eradication, Metabolic Disturbance
Conditions
Keywords
Helicobacter pylori, Eradication, Vonoprazan, Amoxicillin, Gut microbiota
Brief 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.
Interventions
DRUGVonoprazan
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.
DRUGAmoxicillin
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.
DRUGBacillus 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.
Sponsors
Zhongshan Hospital (Xiamen), Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiota | day 0, day 44 (or 58), day 104 (or 118) | Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed