UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028803 |
|---|---|
| Receipt number | 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 | 2021/08/27 13:05:47 |
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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 | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-0065
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
+81-52-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Furune |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-0065
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2602
Homepage URL
s-furune@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
Nagoya University Hospital ethics committee
Address
65 tsurumai-cho, Showa-ku, Nagoya
Tel
0527441902
ethics@med.nagoya-u.ac.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
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
40
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
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 01 | Day |
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
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032460
