UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020794 |
|---|---|
| Receipt number | R000024000 |
| Scientific Title | A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2020/08/02 09:19:49 |
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Basic information
Public title
A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization
Acronym
A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization
Scientific Title
A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization
Scientific Title:Acronym
A randomized, placebo-controlled clinical trial for prophylactic effect of propolis on atopic sensitization
Region
| Japan |
Condition
Condition
Atopic disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Propolis includes arteillin C, vitamins, and minerals and some research suggests propolis may have improvement effect on immune system. This clinical trial verifies whether the immune effect of propolis will improve atopic sensitization of an infant via breast milk. Alternatively, safety of propolis will be assessed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Non-specific IgE is more than 10 IU/mL or antigen-specific IgE is more than 0.34 IU/mL in an infant when 1 year-old.
Key secondary outcomes
1) Atopic asthma bronchitis: Symptom of wheezing at medical inquiry and IgE against mites more than 0.34 IU/mL
2) Atopic dermatitis: Prescription of topical steroid during taking supplements
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
propolis
From entry to blood sampling at 1 year, participants are asked to take propolis (302.4mg/day) for 2 to 10 months.
Interventions/Control_2
placebo
From entry to blood sampling at 1 year, participants are asked to take placebo for 2 to 10 months.
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
| 2 | months-old | <= |
Age-upper limit
| 8 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Mother has atopic symptom; having or had at least one of asthma, atopic dermatitis, food allergy, allergic rhinitis or hay fever in medical inquiry. Not only medical judgment by physician, personal statement is also acceptable.
2) Breast feeding. Combination with artificial milk is also acceptable.
3) Infant is 2-8 month-old; exceptionally if the infant has been suffering before 8 months-old, entry is available till 10 month-old.
4) Infant has dermatitis (eczema, dry skin, etc.). It continuously or intermittently exists more than 1 month although intensive skin care such as soap at bath time is conducted on him/her without any medical anti-inflammatory treatment on local skin. If there is medical intervention, symptom less than 1 month is acceptable.
Key exclusion criteria
1) Mother is under 20 year-old.
2) Infant has significant primary disease other than atopic disease.
3) Mother has allergy against;
Wheat, propolis, honey, perilla oil,farina, geratin, glycerin, pectine, carrageenan, beeswax or lectin (from soybean)
4) Totally artificial milk feeding.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
The Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
urashima@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gen Igarashi |
Organization
The Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
gengeniga@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
東京慈恵会医科大学（東京都）
富士市立中央病院（静岡県）
厚木市立病院（神奈川県）
瀬川小児科アレルギー科医院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | 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
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024000
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| Registered date | File name |
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