Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649709
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2022-11-27
Brief Title:
Helicobacter Pylori and Vonoprazan Dual Therapy
Sponsor:
The First Affiliated Hospital of Nanchang University
Organization:
The First Affiliated Hospital of Nanchang University
Study Overview
Official Title:
Fourteen-day Vonoprazan and Low-or High-dose Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection a Prospective Multi-centers Open-labeled Non-inferior Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our previous study included 119 Helicobacter pyloriH pylori-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either bid or tid plus vonoprazan 20 mg bid for 7 or 10 days Neither 7-or 10-day VA dual therapy with either bid or tid amoxicillin achieved satisfied efficacy ie 90 when given as first-line treatment for H pylori infection This study evaluated the efficacy and safety of low-and high-dose amoxicillin-vonoprazan dual therapy for 14 days as first-line treatment for H pylori in China
Detailed Description:
Upper gastrointestinal endoscopy examinations were performed for all participants and biopsies from gastric antrum and body were obtained All the collected gastric biopsy specimens were sent to Jiangxi Provincial Key Laboratory of Digestive Diseases First Affiliated Hospital of Nanchang University for susceptibility testing of antibiotics The minimum inhibitory concentrations of antibiotics amoxicillin metronidazole clarithromycin levofloxacin and tetracycline were determined by E-test The inhibition zone for furazolidone was determined by the Kirby-Bauer disc diffusion method Detailed procedure for detecting antibiotics resistance were consistent with our previous study A strain was considered as resistant if minimum inhibitory concentration 0125 μgmL for amoxicillin 8 μgmL for metronidazole 1 μgmL for clarithromycin 2 μgmL for levofloxacin 2 μgmL for tetracycline the inhibition zone was 7mm for furazolidone
The detailed demographics and characteristics sex age nationality height weight education status dwelling area history of smoking and alcohol etc were recorded The treatment-related adverse events TEAEs were recorded We defined adherence as good if the participants took 80 drugs of the regimen during the consecutive 14 days The H pylori status after therapy was evaluated by ¹³C-UBT at least 6 weeks after completion of treatment Proton pump inhibitors and antibiotics were stopped at least 2 and 4 weeks before ¹³C-UBT respectively
The stool samples were collected at baseline before treatment week 2 after eradication and week 8-10 confirmation of H pylori status We sent the stool samples from subjects with successful eradication for metagenome DNA extraction and shotgun sequencing to avoid the influence of H pylori eradication failure on gut microbiota Briefly OMEGA Mag-Bind Soil DNA Kit Omega Bio-Tek Norcross GA USA was used to extract total microbial genomic DNA samples Metagenome shotgun sequencing libraries from extracted microbial DNA was constructed by Illumina TruSeq Nano DNA LT Library Preparation Kit which was then sequenced by Illumina NovaSeq platform Illumina USA with PE150 strategy at Personal Biotechnology Co Ltd Shanghai China
Raw sequencing reads were subjected to processing to yield quality-filtered reads suitable for further analysis including removal of adapter and low-quality reads Subsequently minimap2 was utilized to align reads to the host genome of human and eliminate host contamination Gene prediction was carried out on the generated contigs from each sample whose translated protein sequences were subsequently pooled and clustered using mmseqs2 The lowest common ancestor taxonomy of the non-redundant genes was ascertained using mmseqs2 in taxonomy mode by aligning them against a customized database comprising protein sequences of bacteria from GTDB release 207 httpsdataaceuqeduaupublicgtdbdatareleases fungi from NCBI-nr httpsftpncbinlmnihgovblastdbFASTA and viruses from RVDB version 241 httpsrvdbdbiudeledudownload In order to assess the abundance of genes high-quality reads from each sample were mapped onto the contigs using minimap2 and read counts were computed using htseq Abundance values in metagenomes were normalized using copies per kilobase per million mapped reads Clean high-quality reads were processed and profiled with ARGs-OAP version 20 by querying against the SARG version 30-F database which is a structural antimicrobial resistance genes database containing 32 types and 2842 subtypes of antibiotic resistance genes In order to perform the quantification and downstream analysis of diversity indices resistome profiling and prevalence ranking the abundance of antibiotic resistance genes at type and subtype level were normalised to the number of 16S rRNA genes
The detailed demographics and characteristics sex age nationality height weight education status dwelling area history of smoking and alcohol etc were recorded The treatment-related adverse events TEAEs were recorded We defined adherence as good if the participants took 80 drugs of the regimen during the consecutive 14 days The H pylori status after therapy was evaluated by ¹³C-UBT at least 6 weeks after completion of treatment Proton pump inhibitors and antibiotics were stopped at least 2 and 4 weeks before ¹³C-UBT respectively
The stool samples were collected at baseline before treatment week 2 after eradication and week 8-10 confirmation of H pylori status We sent the stool samples from subjects with successful eradication for metagenome DNA extraction and shotgun sequencing to avoid the influence of H pylori eradication failure on gut microbiota Briefly OMEGA Mag-Bind Soil DNA Kit Omega Bio-Tek Norcross GA USA was used to extract total microbial genomic DNA samples Metagenome shotgun sequencing libraries from extracted microbial DNA was constructed by Illumina TruSeq Nano DNA LT Library Preparation Kit which was then sequenced by Illumina NovaSeq platform Illumina USA with PE150 strategy at Personal Biotechnology Co Ltd Shanghai China
Raw sequencing reads were subjected to processing to yield quality-filtered reads suitable for further analysis including removal of adapter and low-quality reads Subsequently minimap2 was utilized to align reads to the host genome of human and eliminate host contamination Gene prediction was carried out on the generated contigs from each sample whose translated protein sequences were subsequently pooled and clustered using mmseqs2 The lowest common ancestor taxonomy of the non-redundant genes was ascertained using mmseqs2 in taxonomy mode by aligning them against a customized database comprising protein sequences of bacteria from GTDB release 207 httpsdataaceuqeduaupublicgtdbdatareleases fungi from NCBI-nr httpsftpncbinlmnihgovblastdbFASTA and viruses from RVDB version 241 httpsrvdbdbiudeledudownload In order to assess the abundance of genes high-quality reads from each sample were mapped onto the contigs using minimap2 and read counts were computed using htseq Abundance values in metagenomes were normalized using copies per kilobase per million mapped reads Clean high-quality reads were processed and profiled with ARGs-OAP version 20 by querying against the SARG version 30-F database which is a structural antimicrobial resistance genes database containing 32 types and 2842 subtypes of antibiotic resistance genes In order to perform the quantification and downstream analysis of diversity indices resistome profiling and prevalence ranking the abundance of antibiotic resistance genes at type and subtype level were normalised to the number of 16S rRNA genes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None