UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005695 |
|---|---|
| Receipt number | 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 11:09:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006713
