SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01513785

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection:a Pilot Study

The efficacy of traditional triple therapy has been decreased to such an unacceptable level as 70% in many areas. The study is based on the hypothesis: the most important factors which influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for initial treatment of H. pylori infection.

NCT01513785 Functional Dyspepsia
MeSH: Dyspepsia Helicobacter Infections

2 Interventions

Name: Rabeprazole and Amoxicillin

Description: Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 10 mg b.i.d.for 14 days.

Type: Drug

group R10A

Name: Amoxicillin and Rabeprazole

Description: Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1 g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 20 mg b.i.d. for 14 days

Type: Drug

group R20A


Primary Outcomes

Description: When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).

Measure: 13C-urea breath test

Time: 4 weeks after treatment

Secondary Outcomes

Description: H. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method.Minimal inhibitory concentrations (MIC) of Metronidazole (Met), Clarithromycin (Cla), and Amoxicillin (Amo) were determined.MIC of Met>8ug/ml, Cla>2ug/ml, Amo>8ug/ml were determined as resistance breakpoints

Measure: antibiotic resistance

Time: 3 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 R10A

A total of forty patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive either Rabeprazole 10 mg b.i.d. and Amoxicillin 1000 mg t.i.d., for 14 days (R10A), or high-dose Rabeprazole 20 mg twice a day (b.i.d.) and Amoxicillin 1000 mg three times a day (t.i.d) (R20A) for 14 days. --- R10A ---


2 R20A

A total of forty patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive either Rabeprazole 10 mg b.i.d. and Amoxicillin 1000 mg t.i.d., for 14 days (R10A), or high-dose Rabeprazole 20 mg twice a day (b.i.d.) and Amoxicillin 1000 mg three times a day (t.i.d) (R20A) for 14 days. --- R10A --- --- R20A ---



HPO Nodes