UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024878 |
|---|---|
| Receipt number | R000028630 |
| Scientific Title | Improvement effect of Japanese apricot (Prunus mume Siebold et Zucc; Ume) on lower intestinal microflora. |
| Date of disclosure of the study information | 2016/11/17 |
| Last modified on | 2016/11/17 16:21:54 |
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Basic information
Public title
Improvement effect of Japanese apricot (Prunus mume Siebold et Zucc; Ume) on lower intestinal microflora.
Acronym
Improvement effect of Japanese apricot on intestinal microflora.
Scientific Title
Improvement effect of Japanese apricot (Prunus mume Siebold et Zucc; Ume) on lower intestinal microflora.
Scientific Title:Acronym
Improvement effect of Japanese apricot on intestinal microflora.
Region
| Japan |
Condition
Condition
healthy stomach, atrophic gastritis
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigete the Improvement effect of Japanese apricot on lower intestinal microflora and serum cytokine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse event
the Improvement effect of Japanese apricot on lower intestinal microflora , serum cytokine, serum triglyceride and serum cholesterol value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Japanese apricot (Prunus mume Siebold et Zucc; Ume) products
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer and those people with atrophic gastritis
Key exclusion criteria
The person of allergy to Japanese apricot, a person with a history of the gastrectomyand Hp erradication, the person who takes PPI and H2 receptor blocker, the person of allergy to peach, a person with the renal disfunction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL
073-447-2300
maekita@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL
073-447-2300
Homepage URL
maekita@wakayama-med.ac.jp
Sponsor or person
Institute
School of Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
japanvscience and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 17 | 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
Date of protocol fixation
| 2013 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 19 | 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
| 2016 | Year | 11 | Month | 17 | Day |
Last modified on
| 2016 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028630
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
