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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028803
Receipt No. R000032460
Scientific Title The change of Gut microbiota caused by Vonoprazan and kestose
Date of disclosure of the study information 2017/08/24
Last modified on 2018/07/05

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Basic information
Public title The change of Gut microbiota caused by Vonoprazan and kestose
Acronym The change of Gut microbiota caused by Vonoprazan and kestose
Scientific Title The change of Gut microbiota caused by Vonoprazan and kestose
Scientific Title:Acronym The change of Gut microbiota caused by Vonoprazan and kestose
Region
Japan

Condition
Condition Gastroduodenal ulcer and after ESD artificial ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the change of Gut microbiota caused by Vonoprazan and kestose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the change of Gut microbiota caused by using Vonoprazan and kestose or placebo for 8 weeks
Key secondary outcomes 1. Ovserbation of the change of ulcer healing caused by kestose
2. Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.)
3. Changes of pathologic and metabolic marker (T.Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin,HbA1c,CRP,TP,ALB etc.)
4. Correlation of gut microbiota and bowel habits
5. Changes of body weight and BMI
6. Metabolome,bile acid and protein analysis of metabolite in feces
7. Correlation between expiratory noble gases,gut microbiota and ulcer healing

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 kestose
Interventions/Control_2 placebo
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients of gastroduodenal ulcer or after ESD artifical ulcer
Key exclusion criteria 1. Patients continuously using PPI or Vonoprazan
2. Women with pregnancy or possible pregnancy
3. Patients with severe renal failure and heart failure
4. Patient who is considered to be inappropriate for entry into the trial by the investigator
5. Medical doctors decided the patients are inappropriate
6. Patient who has allergy to drugs or foods used in this research
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65, Tsuruma-cho, Showa-ku, Nagoya
TEL +81-52-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Furune
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL +81-52-744-2602
Homepage URL
Email s-furune@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization B Food Science Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 24 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032460

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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