UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028846
Receipt No. R000032716
Scientific Title Study on the effect of oral tolerance induction by early ingestion of powdered milk
Date of disclosure of the study information 2017/08/28
Last modified on 2018/02/27

* 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 Study on the effect of oral tolerance induction by early ingestion of powdered milk
Acronym Study on the effect of oral tolerance induction by early ingestion of powdered milk
Scientific Title Study on the effect of oral tolerance induction by early ingestion of powdered milk
Scientific Title:Acronym Study on the effect of oral tolerance induction by early ingestion of powdered milk
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For infants who are at high risk of developing allergies, the incidence of milk allergy is examined in the group who continuously ingested powdered milk, started in the middle, restarted group, and complete breast milk alone group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Percentage of occurrence of immediate milk allergy up to one and a half years in each group
Key secondary outcomes The timing of milk sensitization
Relationship between the amount of milk powder and sensitization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group that had been taking powder milk continuously until 1 year old.
Interventions/Control_2 Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group who was fully breast-fed until 1 year old.
Interventions/Control_3 Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group who started taking milk powder from the middle until 1 year old.
Interventions/Control_4 Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, agains the group who stopped milk powder halfway and resumed again at the age of 1 year old.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
12 months-old <=
Age-upper limit
18 months-old >=
Gender Male and Female
Key inclusion criteria Patients who visited our hospital before one year old and one year old
Key exclusion criteria 1) Gestational age less than 37 weeks.
2) There are severe systemic diseases.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mihoko Iwata
Organization National Hospital Organization Fukuoka Hospital
Division name Pediatrics
Zip code
Address 4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394
TEL 092-565-5534
Email mihokem@mfukuoka2.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mihoko Iwata
Organization National Hospital Organization Fukuoka Hospital
Division name Pediatrics
Zip code
Address 4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394
TEL 092-565-5534
Homepage URL
Email mihokem@mfukuoka2.hosp.go.jp

Sponsor
Institute National Hospital Organization Fukuoka Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 28 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 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
2017 Year 08 Month 26 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.