UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028846
Receipt number 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 2020/06/22 10:30:28

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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 Mihoko
Middle name
Last name Iwata

Organization

National Hospital Organization Fukuoka Hospital

Division name

Pediatrics

Zip code

811-1353

Address

4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394

TEL

092-565-5534

Email

Tomihken0799@gmail.com


Public contact

Name of contact person

1st name Mihoko
Middle name
Last name Iwata

Organization

National Hospital Organization Fukuoka Hospital

Division name

Pediatrics

Zip code

811-1353

Address

4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394

TEL

092-565-5534

Homepage URL


Email

Tomihken0799@gmail.com


Sponsor or person

Institute

National Hospital Organization Fukuoka Hospital

Institute

Department

Personal name



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

National Hospital Organization Fukuoka Hospital

Address

4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394

Tel

092-565-5534

Email

Tomihken0799@gmail.com


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

Completed

Date of protocol fixation

2017 Year 07 Month 19 Day

Date of IRB

2017 Year 07 Month 13 Day

Anticipated trial start date

2017 Year 08 Month 28 Day

Last follow-up date

2019 Year 10 Month 01 Day

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

2020 Year 06 Month 22 Day



Link to view the page

Value
https://center6.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