SNPMiner Trials by Shray Alag


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Report for Mutation A2143G

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 5 clinical trials

Clinical Trials


1 Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance

1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance 2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully 3. Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.

NCT01453036 Peptic Ulcer Helicobacter Pylori Infection Procedure: 23S rRNA point mutation test of Helicobacter pylori Procedure: UBT test & Gastroenterology with biopsy c silver stain
MeSH: Peptic Ulcer
HPO: Peptic ulcer

Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. --- A2143G ---

Primary Outcomes

Description: Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.

Measure: Helicobacter Pylori Eradication Rate

Time: 8 weeks

2 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 ---

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.

3 Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study

The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

NCT03130452 Helicobacter Pylori Infection Drug: Lansoprazole 30mg Drug: Amoxicillin 1.0g Tab Drug: Clarithromycin 500mg Drug: Metronidazole 500 mg

Method> Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. --- A2142G --- --- A2143G ---

Primary Outcomes

Description: Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)

Measure: Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.

Time: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.

Secondary Outcomes

Description: Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug.

Measure: Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin

Time: Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.

Other Outcomes

Description: After taking the treatment drug, take out all remaining medicine in the outpatient clinic room, check the number of remaining medicines, and judge compliance.

Measure: Number of remaining medicines of tailored therapy compared to concomitant therapy

Time: At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.

4 Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance

The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

NCT03884348 Helicobacter Pylori Infection Antibiotic Resistant Strain Drug: proton pump inhibitor, amoxicillin, clarithromycin Drug: proton pump inhibitor, amoxicillin, metronidazole
MeSH: Sprains and Strains

Inclusion Criteria: - Clinical diagnosis of Helicobacter pylori infection Exclusion Criteria: - H. pylori eradication therapy within 1 year, - antibiotics within 4 weeks, - surgery for gastric cancer - malignant tumors other than gastric cancer - end-stage renal disease - liver cirrhosis, - pregnancy Inclusion Criteria: - Clinical diagnosis of Helicobacter pylori infection Exclusion Criteria: - H. pylori eradication therapy within 1 year, - antibiotics within 4 weeks, - surgery for gastric cancer - malignant tumors other than gastric cancer - end-stage renal disease - liver cirrhosis, - pregnancy Helicobacter Pylori Infection Antibiotic Resistant Strain Sprains and Strains Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant. --- A2142G --- --- A2142C --- --- A2143G ---

Primary Outcomes

Description: Number of participant with successful Helicobacter pylori eradication

Measure: Helicobacter pylori eradication rate

Time: 2 year

5 Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection

We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.

NCT04006340 Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation Helicobacter Pylori Infection Combination Product: triple therapy Combination Product: quadruple therapy Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test
MeSH: Infection Communicable Diseases Helicobacter Infections

This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. --- A2142G --- --- A2143G ---

Primary Outcomes

Description: Eradication rate of H. pylori infection

Measure: Eradication rate

Time: 13C-UBT at least 4 weeks after completion of treatment


HPO Nodes


Peptic ulcer
Genes 27
HPGD ARID1B GTF2I GTF2IRD1 CDKN2B SLCO2A1 BAZ1B CLIP2 CDC73 CDKN2C CISD2 ELN CISD2 CDKN1B AP2S1 RFC2 LIMK1 PLA2G4A MEN1 CDKN1A ERGIC1 CDC73 MEN1 CDKN1B WFS1 GNA11 TBL2
Gastritis
Genes 16
TTC37 RIPK1 FAS IL1B CASP10 SKIV2L IL1RN FAS FASLG FOXP3 RASGRP1 LRBA KRAS AIRE PRKCD CDH1