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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030214
Receipt No. 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 2019/03/01

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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

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
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Reumatology
Zip code
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
Middle name
Last name Kiyotake Ogura
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code
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
Institute National Hospital Organization Sagamihara National Hospital
Department of Pediatrics
Institute
Department

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
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 [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)
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[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
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
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.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


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