UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037227 |
|---|---|
| Receipt number | R000041441 |
| Scientific Title | Clinical effect of kestose on tolerance acquisition in children with cow's milk allergy |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/07/01 18:04:16 |
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Basic information
Public title
Effect of kestose on cow's milk allergy
Acronym
Effect of kestose on cow's milk allergy
Scientific Title
Clinical effect of kestose on tolerance acquisition in children with cow's milk allergy
Scientific Title:Acronym
Clinical effect of kestose on tolerance acquisition in children with cow's milk allergy
Region
| Japan |
Condition
Condition
cow's milk allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore combined effects of kestose and hypoallergenic milk on the acquisition of tolerance toward cow's milk allergy in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The acquisition of tolerance toward cow's milk
Key secondary outcomes
Gut microbiota and SCFA concentrations in fecal samples collected at the beginning of the test, 3 months, and 6 months after the beginning of the test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Treat 2 grams of kestose (4 grams if over 10 years old) and hypoallergenic milk every day for 6 months
Interventions/Control_2
Treat only and hypoallergenic milk every day 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
| 4 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Child patients diagnosed as milk allergy
Key exclusion criteria
1) Medical doctors decided the child patient are inappropriate
2) Child patient who daily take pro/prebiotics agent
3) Child patients who take antibacterial drug
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Rumiko |
| Middle name | |
| Last name | Shibata |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Pediatrics
Zip code
811-1394
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka
TEL
092-565-5534
rm-shiba@k7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Rumiko |
| Middle name | |
| Last name | Shibata |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Pediatrics
Zip code
811-1394
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka
TEL
092-565-5534
Homepage URL
rm-shiba@k7.dion.ne.jp
Sponsor or person
Institute
National Hospital Organization Fukuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
B Food Science Co., 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
National Hospital Organization Fukuoka Hospital Ethical Review Committee
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka
Tel
092-565-5534
rm-shiba@k7.dion.ne.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
| 2019 | Year | 08 | 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
42
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
| 2018 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Last modified on
| 2019 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
