Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, rescue therapy, minocycline, tetracycline
Brief summary
The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.
Interventions
DRUGVonoprazan
Potassium competitive acid blocker
DRUGBismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Antibiotics for H. pylori eradication
Antibiotics for H. pylori eradication
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection and with previous treatment experience
Exclusion criteria
* subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * Previous history of tuberculosis * Allergy to any of the study drugs * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | Within 7 days after completion of therapy | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney. |
| Compliance rate | Within 7 days after completion of therapy | Compliance was defined as poor when they had taken less than 80% of the total medication |
Countries
China
Outcome results
None listed