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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005695
Receipt No. R000006713
Scientific Title A randomized, open-label, parallel group study to evaluate the efficacy and safety of the oral administration of Bifidobacterium animalis subsp. lactis LKM512 in patients with atopic dermatitis
Date of disclosure of the study information 2011/06/01
Last modified on 2012/12/25

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Basic information
Public title A randomized, open-label, parallel group study to evaluate the efficacy and safety of the oral administration of Bifidobacterium animalis subsp. lactis LKM512 in patients with atopic dermatitis
Acronym Efficacy and safety of Bifidobacteria LKM512 in patient with atopic dermatitis
Scientific Title A randomized, open-label, parallel group study to evaluate the efficacy and safety of the oral administration of Bifidobacterium animalis subsp. lactis LKM512 in patients with atopic dermatitis
Scientific Title:Acronym Efficacy and safety of Bifidobacteria LKM512 in patient with atopic dermatitis
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of the oral administration of Bifidobacteria LKM512 in patients with atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Score of itch after 4 weeks and 8 weeks of administration
Key secondary outcomes Improvement of dermatological symptoms QOL
Intestinal microbiota

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The volunteer were given an 8-week treatment with oral administration of Bifidobacteria LKM512 tablet (10 billion bacterial cells/tablet) two times per day.
Interventions/Control_2 The volunteer were given an 8-week treatment with oral administration of placebo tablet without Bifidobacteria LKM512 two times per day.
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

Not applicable
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who were diagnosed as having moderate or severe atopic dermatitis according to the criteria of Hanifin and Rajka.
(2) Male or female subjects (under 75 years old)
Key exclusion criteria (1) Patients who are taking oral Bifidobacteria LKM512 daily
(2) Patients who were diagnosed as having milk allergy
(3) Patients who was enrolled in other trails within a month.
(4) Inappropriate cases evaluated by doctors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuharu Matsumoto
Organization Kyodo Milk Industry Co. Ltd.
Division name Research Laboratories
Zip code
Address 20-1 Hirai, Hinode-cho, Nishitama-gun, Tokyo 190-0182 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization INCREASE Co.,Ltd.
Division name R&D Dept
Zip code
Address 3-29 Ichigayahonmuracho, Shinjyuku-ku,Tokyo 162-0845 JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Kyodo Milk Industry Co. Ltd.
Institute
Department

Funding Source
Organization Kyodo Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yoga Allergy Clinic
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 用賀アレルギークリニック(東京都) Yoga Allergy Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 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
2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 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
2011 Year 06 Month 01 Day
Last modified on
2012 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006713

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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