UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006209 |
|---|---|
| Receipt number | R000007314 |
| Scientific Title | Effect and safety of supplementation of Lactobacilli powder to the patients with atopic dermatitis accompanied by food allergy |
| Date of disclosure of the study information | 2011/08/22 |
| Last modified on | 2015/08/22 09:08:19 |
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Basic information
Public title
Effect and safety of supplementation of Lactobacilli powder to the patients with atopic dermatitis accompanied by food allergy
Acronym
Supplementation of Lactobacilli powder to the patients with atopic dermatitis
Scientific Title
Effect and safety of supplementation of Lactobacilli powder to the patients with atopic dermatitis accompanied by food allergy
Scientific Title:Acronym
Supplementation of Lactobacilli powder to the patients with atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect and safety of supplementation of dry powder containing 20 mg or 0.2 mg of Lactobacilli acidophils L-92 for 24 weeks to the infants with atopic dermatitis accompanied by food allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease in SCORAD index after 24 week
Key secondary outcomes
QOL, Dose of topical corticosteroid, intestinal flora, eosinophils, IgE, LDH, AST, ALT, TARC after 24 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Supplementation of dry powder containing 20 mg of Lactobacillus acidophils L-92 once a day for 24 weeks.
Interventions/Control_2
Supplementation of dry powder containing 0.2 mg of Lactobacillus acidophils L-92 once a day for 24 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
| 10 | months-old | <= |
Age-upper limit
| 36 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. Definitive atopic dermatitis which requires daily topical corticosteroid ointment.
2. Undergoing the standard treatment and skin care based on the Japanese guideline for atopic dermatitis.
3. Associated with food allergy, or avoiding some food due to the high level of specific IgE test.
4. NOT taking probiotic food or drugs daily to improve the intestinal flora.
5. NOT associated with bacterial or fungal skin infection, or any other skin diseases.
Key exclusion criteria
1. Suspected NOT to be able to take the powder food daily.
2. Clinical history of severe anaphylaxis caused by the small amount of milk product.
3. Any severe complications such as diabetes, gastrointestinal, renal, or heart diseases.
4. Clinical history of hypersensitivity to steroid ointment, skin moisturizer or the test food.
5. Undergoing or planning any other intervention study.
6. Any other inappropriate conditions judged by the participant doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Komei Ito |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
Address
1-2 Osakada, Morioka, Obu, Aichi, JAPAN
TEL
0562-43-0500
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komei Ito |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
Address
1-2 Osakada, Morioka, Obu, Aichi, JAPAN
TEL
0562-43-0500
Homepage URL
Sponsor or person
Institute
NPO Allergy Support Network
Institute
Department
Personal name
Funding Source
Organization
NPO Allergy Support Network
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Calpis Co.
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
あいち小児保健医療総合センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007314
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