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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013374
Receipt No. R000015599
Scientific Title Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Date of disclosure of the study information 2014/03/08
Last modified on 2019/03/12

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Basic information
Public title Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Acronym oral immunotherapy with hypoallergenic formula
Scientific Title Effect of oral immunotherapy with hypoallergenic formula for severe milk allergenic patients
Scientific Title:Acronym oral immunotherapy with hypoallergenic formula
Region
Japan

Condition
Condition severe milk allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of oral immunotherapy with hypoallergenic formula for severe milk allergic children.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The improvement of tolerance to milk of children in each study group
Key secondary outcomes Milk specific-IgE, peripheral basophil activation against milk, milk specific-T cell activation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
Interventions/Control_2 drink extensively hydrolyzed cow's milk protein-based formula once per day for 8 weeks in double blind setting, after then drink partially hydrolyzed cow's milk protein-based formula once per day for 8 weeks in open setting
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
1 years-old <
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Eligible participants were aged 1-20 years with an immediate hypersensitivity reaction after small amount of milk ingestion.
Key exclusion criteria Use of antihistamines within three days prior to double blind placebo controlled food challenge (DBPCFC)
Uncontrolled bronchial asthma.
judged inappropriate for this study by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuo
Organization Fujita Health University, Banbuntane Hotokukai Hospital
Division name Department of Pediatrics
Zip code
Address 3-6-10 Otobashi, Nakagawa Ward, Nagoya Aichi.Japan
TEL 052-323-5649
Email urisu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Inuo
Organization Fujita Health University
Division name Department of Pediatrics
Zip code
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
TEL 0562-93-2469
Homepage URL http://www.fujita-hu.ac.jp/~pedia/pg146.html
Email inuo@mbh.nifty.com

Sponsor
Institute Fujita Health University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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 藤田保健衛生大学

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 08 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 No longer recruiting
Date of protocol fixation
2012 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 08 Day
Last follow-up date
2015 Year 06 Month 02 Day
Date of closure to data entry
2015 Year 06 Month 02 Day
Date trial data considered complete
2015 Year 06 Month 02 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 08 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015599


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