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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040025
Receipt No. 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 2020/10/01

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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
Email 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
Email s.sho.salubriter.mail@gmail.com

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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