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
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
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
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
