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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021837
Receipt No. 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

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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
Email 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
Email yamanoka@ior.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025179

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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