UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030214
Receipt number R000034513
Scientific Title Randomized controlled trial of intake of milk in infancy by high-risk infants to prevent milk allergy
Date of disclosure of the study information 2017/12/01
Last modified on 2021/06/03 11:59:37

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Basic information

Public title

Randomized controlled trial of intake of milk in infancy by high-risk infants to prevent milk allergy

Acronym

Prevention of infants' milk allergy (PIMA study)

Scientific Title

Randomized controlled trial of intake of milk in infancy by high-risk infants to prevent milk allergy

Scientific Title:Acronym

Prevention of infants' milk allergy (PIMA study)

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate in a multicenter randomized controlled trial whether the introduction of a low-dose of heated milk in infancy for high-risk infants prevents the development of milk allergy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Proportion of patients who developed an immediate type milk allergy by the age of 2 years
(Positive rate of intake of 3 ml or 25 ml of heated milk oral food challenge test)

Key secondary outcomes

Proportion of patients who could take 50 ml of unheated milk by the age of 3 years

Severity of each oral food challenge test

Prognosis of other food allergies


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Perform a 3 ml heated milk OFC among those aged 6 to 11 months old. If the OFC is negative, the patients take 3 ml of milk at home regularly until the next OFC.

Interventions/Control_2

Eliminate milk completely until 18 months old, and then perform 3 ml of heated milk OFCs among those aged 18 to 24 months old. If the OFC is negative, patients take 3 ml of milk at home regularly until the next OFC.

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

6 months-old <=

Age-upper limit

11 months-old >=

Gender

Male and Female

Key inclusion criteria

Sensitized to milk
Food allergy other than milk (for example, egg, wheat, and soy)

Key exclusion criteria

History of immediate symptoms after consuming milk.
Regular intake of more than 3 ml of milk before initiation of the trial
Non-IgE mediated gastrointestinal food allergy after consuming milk
Severe (uncontrolled) atopic dermatis before initiation of the trial

Target sample size

128


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Ebisawa

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Reumatology

Zip code

252-0392

Address

18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan, 252-0392

TEL

042-742-8311

Email

ebisawa.motohiro.cg@mail.hosp.go.jp


Public contact

Name of contact person

1st name Kiyotake
Middle name
Last name Ogura

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

Address

18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan, 252-0392

TEL

042-742-8311

Homepage URL


Email

ogura.kiyotake.yg@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital
Department of Pediatrics

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Sagamihara National Hospital

Address

18-1, Sakuradai, Minami-ku, Sagamihara-city, Kanagawa, Japan, 252-0392

Tel

042-742-8311

Email

222-rinri@mail.hosp.go.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

[国立病院機構;National Hospital Organization(NHO)]
相模原病院;Sagamihara National Hospital(神奈川県)
仙台医療センター;Sendai Medical center(宮城県)
下志津病院;Shimosizu National Hospital(千葉県)
栃木医療センター;Tochigi Medical center(栃木県)
横浜医療センター;Yokohama Medical center(神奈川県)
神奈川病院;Kanagawa National Hospital(神奈川県)
長良医療センター;Nagara Medical center(岐阜県)
名古屋医療センター;Nagoya Medical center(愛知県)
三重病院;Mie National Hospital(三重県)
熊本医療センター;Kumamoto Medical center(熊本県)
南岡山医療センター;Minami-Okayama Medical center(岡山県)
福岡病院;Fukuoka National Hospital(福岡県)
四国こどもとおとなの医療センター;Shikoku Medical center for children and adults(香川県)
福山医療センター;Fukuyama Medical center(広島県)
-------------------------------------------------------------------
[国立病院機構以外の病院(non-NHO hospital)]
自治医科大学附属さいたま医療センター;Jichi Medical University Saitama Medical Center(埼玉県)
六甲アイランド甲南病院;Rokko Island Konan Hospital(兵庫県)
金沢城北病院;Kanazawa Jouhoku Hospital(石川県)
長野県立こども病院;Nagano Children's Hospital(長野県)
愛和病院;Aiwa Hospital(埼玉県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 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

Enrolling by invitation

Date of protocol fixation

2017 Year 11 Month 27 Day

Date of IRB

2017 Year 11 Month 15 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 08 Month 31 Day

Date trial data considered complete

2024 Year 12 Month 31 Day

Date analysis concluded

2025 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 01 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=R000034513


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name