UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022264 |
|---|---|
| Receipt number | R000025652 |
| Scientific Title | Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2016/11/09 11:52:12 |
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Basic information
Public title
Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases
Acronym
Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases
Scientific Title
Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases
Scientific Title:Acronym
Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases
Region
| Japan |
Condition
Condition
purine metabolism
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Lactobacillus gasseri PA-3 on purine bases metabolism in human
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum urate level and change in urate level
Key secondary outcomes
Urine urate excretion and change in urate excretion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Yogurt containing Lactobacillus gasseri PA-3
Interventions/Control_2
Yogurt without containing Lactobacillus gasseri PA-3
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
Key inclusion criteria
healthy volunteer
1)20 years of age or older male
Key exclusion criteria
1)Subjects with a history of hyperuricemia or gout
2)Subjects with severe or progressive disorders and symptoms
3)Subjects taking functional foods for hyperuricemia
4)Subjects with food (including dairy product) allergy
5)Subjects with lactose intolerance
6)Subjects who are judged ineligible by the site investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji, Moriwaki |
Organization
Hyogo college of medicine
Division name
Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL
0798-45-6473
moriwaki@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kurajoh, Masafumi |
Organization
Hyogo college of medicine
Division name
Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL
0798-45-6473
Homepage URL
mkurajoh@gmail.com
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
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 | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | 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 | 05 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025652
