An interventional study of esomeprazole plus amoxicillin and amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole in H. Pylori Infection, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.
H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.
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Exclusion Criteria:
esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group
Drug: esomeprazole plus amoxicillin
furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy
Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
Drug pages: Esomeprazole · Amoxicillin
amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days
Also known as: HDDT
Drug pages: Amoxicillin · Furazolidone · Bismuth · Esomeprazole
amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days
Also known as: FT
eradication rate
eradication rate of H pylori, presenting with negative results on the 13C-UBT test
Time frame: 42 days
frequency of the adverse events
incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
Time frame: 42 days
compliance rate of the drugs
Compliance was defined as good when they had taken more than 80% of the total medication.
Time frame: 42 days
Plan to share: Yes — Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.
Access criteria: Emails could be sent to the emails below to obtain the shared data: chen.jie5@zs-hospital.sh.cn, weng.chengzhao@zsxmhospital.com
Started Jan 2021 (actual). Primary completion is estimated for Dec 2022, 23 months after the start.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Esomeprazole · Amoxicillin