SNPMiner Trials by Shray Alag

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Report for Mutation A2144G

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 Helicobacter Pylori Eradication in Mexico With a Levofloxacin-containing Scheme Versus Clarithromycin-based Triple Therapy: a Randomized, Open-label, Non-inferiority, Phase 3b Trial.

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)
MeSH: Gastritis
HPO: Gastritis

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 ---

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