UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034513