UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027837 |
|---|---|
| Receipt number | R000031627 |
| Scientific Title | Randomized controlled trials involving placebo subjects as to whether infants with atopic dermatitis can reduce the incidence of food allergies after 1 year of age by ingesting multiple foods from early stage |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2021/06/03 19:34:27 |
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Basic information
Public title
Randomized controlled trials involving placebo subjects as to whether
infants with atopic dermatitis can reduce the incidence of food allergies
after 1 year of age by ingesting multiple foods from early stage
Acronym
Preventive effect of food allergy by ingesting multiple foods from early
stage
Scientific Title
Randomized controlled trials involving placebo subjects as to whether
infants with atopic dermatitis can reduce the incidence of food allergies
after 1 year of age by ingesting multiple foods from early stage
Scientific Title:Acronym
Preventive effect of food allergy by ingesting multiple foods from early
stage
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preventive effect of food allergy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of food allergy episodes after powder intervention was assessed at 18 months old by the physician responsible for each participant.
Key secondary outcomes
Concentrations of serum IgE specific to egg white, milk, wheat, soybeans, buckwheat, and peanuts together with TARC concentrations measured at 11-13 months.
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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Mix powder containing a small amount of egg, milk, wheat, soybean, buckwheat, peanut /Probiotics
Interventions/Control_2
Probiotics
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
| 3 | months-old | <= |
Age-upper limit
| 5 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Atopic dermatitis diagnosed by a doctor
Key exclusion criteria
Child whose birth weight is less than 2500 g or gestational age is less than 37 weeks
Child who had anaphylactic shock by food in the past
Child diagnosed with congenital immunodeficiency
In addition, the child judged to be inappropriate for research researcher
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Nishimura |
Organization
Nishimura Pedeatric Clinic
Division name
Division of pediatrics
Zip code
582-0021
Address
Kokubuhonmachi 3-9-3, Kashiwara city, Osaka 582-0021 Japan
TEL
072-978-6597
tatsuo172460@dc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Nishimura |
Organization
Nishimura Pediatric Clinic
Division name
Division of pediatrics
Zip code
582-0021
Address
Kokubuhonmachi 3-9-3, Kashiwara City, Osaka 582-0021 Japan
TEL
072-978-6597
Homepage URL
tatsuo172460@dc4.so-net.ne.jp
Sponsor or person
Institute
Nishimura Pediatric Clinic
Institute
Department
Personal name
Funding Source
Organization
Nishimura Pediatric Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishimura Pediatric Clinic
Address
Kokubuhonmachi 3-9-3, Kashiwara city, Osaka 582-0021 Japan
Tel
072-978-6597
tatsuo172460@dc4.so-net.ne.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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
120
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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031627
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/18 | Clinical Protocol final.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
