UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050668 |
|---|---|
| Receipt number | R000057725 |
| Scientific Title | A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy |
| Date of disclosure of the study information | 2024/03/24 |
| Last modified on | 2023/03/24 13:11:14 |
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Basic information
Public title
A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy
Acronym
A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy
Scientific Title
A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy
Scientific Title:Acronym
A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy
Region
| Japan |
Condition
Condition
Caw's milk allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of soy formula on enhancing sensitization to soybeans
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in soybean skin prick test and soybean-specific IgE antibody titers after 6 months
Key secondary outcomes
Incidence of soybean allergy at 6 months and incidence of adverse events at 6 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants were instructed to consume 40 and more ml of soy formula per day 3 and more times per week for less than 7 months of age, and 80 and more ml per day 3 and more times per week for 7 and more months of age for 6 months.
Interventions/Control_2
Participants were instructed to consume 40 and more ml of hydrolyzed formula per day 3 and more times per week for less than 7 months of age, and 80 and more ml per day 3 and more times per week for 7 and more months of age for 6 months.
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
| 2 | months-old | <= |
Age-upper limit
| 12 | months-old | > |
Gender
Male and Female
Key inclusion criteria
The infants who eliminated cow's milk due to a diagnosis or suspicion of immediate-type cow's milk allergy and whose blood tests showed soybean-specific IgE level was less than 0.35 kUA/L
Key exclusion criteria
Preterm infants, renal-impaired infants, congenital hypothyroid infants, or infants who were already consuming adequate amounts of regular milk or dairy products, or soy formula were excluded.
Target sample size
40
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 Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Fusayasu |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
Homepage URL
nen19842000@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Japan, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara Hospital Ethics Committee of the National Hospital Organization
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 24 | 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
28
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057725
