UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030805 |
|---|---|
| Receipt number | R000034872 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group study to explore the efficacy of fermented citrus juice containing lactic acid bacteria on the oral immunotherapy for cow's milk allergy: a pilot study |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2019/06/12 20:47:37 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group study to explore the efficacy of fermented citrus juice containing lactic acid bacteria on the oral immunotherapy for cow's milk allergy: a pilot study
Acronym
TOY Study: Tokyo Oral Immunotherapy and Probiotics for Milk allergy Study
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group study to explore the efficacy of fermented citrus juice containing lactic acid bacteria on the oral immunotherapy for cow's milk allergy: a pilot study
Scientific Title:Acronym
TOY Study: Tokyo Oral Immunotherapy and Probiotics for Milk allergy Study
Region
| Japan |
Condition
Condition
cow's milk allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of citrus juice fermented with lactic acid bacteria on the oral immunotherapy for cow's milk allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of participants who were improved on their threshold dose to cow's milk provoked with oral food challenge test after completing the intervention for 24 weeks.
Key secondary outcomes
Adherence
-consumed volume and days of taking the study juice of taking the study juice
Feasibility
-perticipation rate of the study
-withdrawal rate of the study
-deviation rate of the study
Efficacy
-the change from baseline after the end of intervention for 24 weeks in cow's milk, casein, and beta-lactoglobulin-specific IgE in serum.
-the change from baseline after the end of intervention for 24 weeks in cow's milk, casein, and beta-lactoglobulin-specific IgG4 in serum.
-the dose of milk intake in oral immunotherapy at the end of the intervention for 24 weeks.
Exploratory
-the change from baseline after the end of intervention for 24 weeks in cytokines and chemokines.
-gut microbiota after the end of intervention for 24 weeks
-the change from baseline after the end of intervention for 24 weeks in gut microbiota
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
125ml citrus juice fermented with lactic acid bacteria and oral immunotherapy for cow's milk allergy every day for 24 weeks
Interventions/Control_2
125ml citrus juice without lactic acid bacteria (placebo) and oral immunotherapy for cow's milk allergy every day for 24 weeks
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) cow's milk allergy diagnosed by oral food challenge test
2) children who have a plan to take oral immunotherapy for cow's milk allergy
3) 1-18 years old children with parental signed informed consent.
4) Voluntary willingness and ability to comply with the study requirements and procedure after obtaining informed consent.
Key exclusion criteria
1) allergy to study juice and citrus
2) Taking oral immunotherapy for the other foods except cow's milk
3) Children born before 37 weeks of gestation
4) Twin or multiple birth
5) Children who participate in the other clinical studies
6)Children whose siblings participate in this study
7) Taking immunosuppressive agents and/or oral and/or intravenous steroids
8) Children whose family may not complete all study visits because of house-moving
9) Parents unable to understand Japanese
10) Children with any severe comorbidity
11)Children judged as inappropriate for the study by a study doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Ohya |
Organization
National Center for Child Health and
Development
Division name
Division of Allergy, Department of Medical Subspecialties
Zip code
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
+81-3-3416-0181
ohya-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiwako Yamamoto-Hanada |
Organization
TOY Study Coordinating Office
Division name
Division of Allergy, National Center for Child Health and Development
Zip code
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
+81-3-3416-0181
Homepage URL
allergy_research@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and
Development
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034872
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