UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040025 |
|---|---|
| Receipt number | R000045627 |
| Scientific Title | Long term follow up and comparative study of fecal microbiota after vonoprazan and low-dose amoxicillin dual therapy or vonoprazan-based triple therapy for Helicobacter pylori infection |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/10/04 20:33:18 |
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Basic information
Public title
Long term follow up and comparative study of fecal microbiota after vonoprazan and low-dose amoxicillin dual therapy or vonoprazan-based triple therapy for Helicobacter pylori infection
Acronym
Long term follow up of fecal microbiota after vonoprazan dual or triple therapies for H. pylori infection
Scientific Title
Long term follow up and comparative study of fecal microbiota after vonoprazan and low-dose amoxicillin dual therapy or vonoprazan-based triple therapy for Helicobacter pylori infection
Scientific Title:Acronym
Long term follow up of fecal microbiota after vonoprazan dual or triple therapies for H. pylori infection
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the changes of fecal microbiota 1 year after vonoprazan dual or triple therapies for Helicobacter pylori infection.
Basic objectives2
Others
Basic objectives -Others
The composition ratios of bacterial taxa and alpha and beta diversities will be evaluated in both treatments.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of fecal microbiota between baselines and 1 year after the treatments.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan 20 mg twice/day and amoxicillin 750 mg twice/day for 7 days.
Interventions/Control_2
vonoprazan 20 mg twice/day, amoxicillin 750 mg twice/day, and clarithromycin 200 mg twice/day for 7 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The patients who have participated the previous randomized controlled trial of vonoprazan-based dual or triple therapies for first line H. pylori eradication (UMIN000034140) and submitted fecal samples before the treatments.
2. Written informed consent
Key exclusion criteria
1. Lack of informed consent
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Gotoda |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
takujigotoda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Yuri Kumiai General Hospital
Address
38, Kamaguchiazaieato, Yurihonnjoshi, Akita, Japan
Tel
0184-27-1200
soumukanri@yuri-hospital.honjo.akita.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JA秋田厚生連由利組合総合病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045627
