UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of yogurt containing Lactobacillus gasseri PA-3 on intestinal absorption of dietary purine bases
Title of the study (Brief title)	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	Yuji, Moriwaki
Organization	Hyogo college of medicine
Division name	Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6473
Email	moriwaki@hyo-med.ac.jp

Public contact
Name of contact person	Kurajoh, Masafumi
Organization	Hyogo college of medicine
Division name	Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6473
Homepage URL
Email	mkurajoh@gmail.com

Sponsor
Institute	Hyogo college of medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025652