SNPMiner Trials (Home Page)
Report for Mutation A21443C
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
The goal of this trial is to compare the non-inferiority efficacy and safety of two different
treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily
(PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily
(CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both
schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP
infection. One month after finishing each treatment, C13-urea breath testing will be required
to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance
mutations in HP strains by fluorescence in situ hybridization (FISH).
NCT02726269 Helicobacter Pylori Gastritis Drug: CLA (Clarithro+Lanso+Amoxi) Drug: PLA (Panto+Levoflox+Azithro)
The probe for H. pylori identification (Hpy 1)
(5'CACACCTGACTGACTATCCCG-3') will be labeled with fluorescein isothiocyanate (FITC) that
provides a green signal, and the probes that detect the three most prevalent
clarithromycin-resistance mutations (ClaR1 (A2143G) 5'CGGGGTCTTCCCGTCTt-3', ClaR2 (A2144G)
5'CGGGGCTCTCCGTCTT-3', and ClaR3 (A21443C) 5-CGGGGTCTTGCCGTCTT-3') will be labeled with red
fluorochrome (Cy3). --- A2143G --- --- A2144G --- --- A21443C ---
Primary Outcomes
Measure: HP eradication rate calculated from negative 13C-urea breath tests.
Time: Four weeks after the end of the allocated treatment.
Secondary Outcomes
Measure: Determine the frequency of Clarithromycin-resistance mutations by fluorescence in situ hybridization (FISH).
Time: Within a month after taking gastric endoscopy biopsy to confirm the diagnosis of HP infection.
Measure: Compare the proportion of Clarithromycin-resistance mutations determined by FISH with the HP eradication rate calculated.
Time: A week after both proportions are calculated.
Other Outcomes
Measure: Percentage and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) in each group (PLA vs CLA).
Time: Up to a month after the end of both treatments.
Measure: Proportion of treatments prematurely suspended due to AEs or SAEs in each group (PLA vs CLA).
Time: Within ten days after each treatment is randomly allocated.
HPO Nodes
Genes 16
TTC37 RIPK1 FAS IL1B CASP10 SKIV2L IL1RN FAS FASLG FOXP3 RASGRP1 LRBA KRAS AIRE PRKCD CDH1 hr>