UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046749 |
|---|---|
| Receipt number | R000053332 |
| Scientific Title | Efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2024/08/08 14:22:05 |
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Basic information
Public title
Efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy
Acronym
Low dose oral immunotherapy with heated milk powder
Scientific Title
Efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy
Scientific Title:Acronym
Low dose oral immunotherapy with heated milk powder
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of low-dose oral immunotherapy with heated milk powder in patients with severe milk allergy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of adverse reactions
Key secondary outcomes
(1)Rate of 25ml short-term unresponsiveness (STU) at 1, 2 and 3 years. 25ml STU is defined as a negative result of an oral food challenge (OFC) with 25ml of heated milk and no symptom with consumption of 25ml of heated milk at home thereafter.
(2)Changes in blood test values including total IgE, specific IgG and specific IgG4 for milk, casein, alpha-lactalbumin and beta-lactoglobulin
(3)Rate of patients with difficulty in increasing dose
(4)Adverse reactions by organ, severity of adverse reactions, treatment of adverse reactions and frequency of emergency room visits
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The intervention group will be treated with oral immunotherapy using heated milk powder. During hospitalization, the ingestion of very low dose of heated milk will be started, and the dose which patients can consume without symptom will be clarified. The dose of heated milk powder will be gradually increased to a maintenance dose with 3mL of heated milk at home, thereafter, the consumption of 3ml will be continued. After 1 year, the OFC with 25ml of heated milk will be performed after 2 weeks of complete avoidance.
Interventions/Control_2
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 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have objective symptoms with consumption of 0.2 ml of milk or less before oral immunotherapy
Key exclusion criteria
Patients deemed inappropriate to perform oral immunotherapy by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Kiyoka |
| Middle name | |
| Last name | Yshimoto |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
kiyo.dis55@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Sagamihara National Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
kiyo.dis55@gmail.com
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
| 2022 | Year | 01 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053332
