Dyspepsia Clinical Trial
Official title:
Prospective, Randomized Controlled Trial Comparing Amoxicillin and Metronidazole Based Bismuth-containing Quadruple Therapy With Amoxicillin and Clarithromycin Based Quadruple Therapy for First-line Helicobacter Pylori Eradication
No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.
Status | Completed |
Enrollment | 215 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment - Ability and willingness to participate in the study and to sign and give informed consent - confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture. Exclusion Criteria: - patients with peptic ulcer - previous H. pylori eradication therapy - Age below 18 years - major systemic diseases - previous gastric surgery - pregnancy or breastfeeding - allergy to any of the study drugs - receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to inclusion |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Lu H, Zhang W, Graham DY. Bismuth-containing quadruple therapy for Helicobacter pylori: lessons from China. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1134-40. doi: 10.1097/MEG.0b013e3283633b57. Review. — View Citation
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084. — View Citation
Sun Q, Liang X, Zheng Q, Liu W, Xiao S, Gu W, Lu H. High efficacy of 14-day triple therapy-based, bismuth-containing quadruple therapy for initial Helicobacter pylori eradication. Helicobacter. 2010 Jun;15(3):233-8. doi: 10.1111/j.1523-5378.2010.00758.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate | Determine MIC of amoxicillin, clarithromycin, and metronidazole by the twofold agar dilution method. | 2 months | No |
Primary | Eradication rate of Helicobacter pylori | Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group | 2 months | No |
Secondary | Frequency of side effects of each treatment | Score side effects as mild, moderate or severe according to their influence on daily activities | 2 months | Yes |
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