UMIN-CTR Clinical Trial

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
Email	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
Email	gengeniga@gmail.com

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024000