UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021837 |
|---|---|
| Receipt number | R000025179 |
| Scientific Title | Hypouricemic effects of yogurt containing Lactobacillus gasser PA-3 for patients with hyperuricemia and/or gout randomized, double-blind, placebo-controlled comparison study |
| Date of disclosure of the study information | 2016/04/08 |
| Last modified on | 2018/07/20 14:28:34 |
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Basic information
Public title
Hypouricemic effects of yogurt containing Lactobacillus gasser PA-3 for patients with hyperuricemia and/or gout randomized, double-blind, placebo-controlled comparison study
Acronym
A study on the effect of the yogurt containing Lactobacillus gasseri PA-3 on uric acid level.
Scientific Title
Hypouricemic effects of yogurt containing Lactobacillus gasser PA-3 for patients with hyperuricemia and/or gout randomized, double-blind, placebo-controlled comparison study
Scientific Title:Acronym
A study on the effect of the yogurt containing Lactobacillus gasseri PA-3 on uric acid level.
Region
| Japan |
Condition
Condition
hyperuricemia and/or gout
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the Lactobacillus gasseri PA-3 on uric acid level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum uric acid level or Serum uric acid concentration change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A 100g Yogurt non-containing Luctobacillus gasseri PA-3 is give for 8 weeks
Interventions/Control_2
A 100g Yogurt concentration Luctobacillus gasseri PA-3 give for 8 weeks
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
All of them have been treated for hyperuricemia and/or gout at the hospital of Tokyo Women's Medical University. They met the following criteria:
1.Subjects who aged twenty years.
2.More subjects who had been taking hyperuricemia drug.
3.Subjects who low possibility of developing gouty arthritis after cessation of the drug for twelve weeks or more.
Key exclusion criteria
1.Subjicts with sever or progressive disorder.
2.Subjicts with not reasonable to discontinue the drug for hyperuricemia or gout.
3.Subjicts with routine use of health food.
4.Subjicts with food allergies.
5.Subjects who are judged ineligible by the principal investigator or subinvestigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Nakayama |
Organization
Tokyo Women's Medical University
Division name
Institute of Rheumatology
Zip code
Address
10-22 Kawada-cyo,Shinjuku-ku,Tokyo 162-0054,Japan
TEL
03-5269-1711
yamanoka@ior.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Nakayama |
Organization
Tokyo Women's Medical University
Division name
Institute of Rheumatology
Zip code
Address
0-22 Kawada-cyo,Shinjuku-ku,Tokyo 162-0054,Japan
TEL
03-5269-1711
Homepage URL
yamanoka@ior.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
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
東京女子医科大学膠原病リウマチ痛風センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 09 | Month | 24 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025179
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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