UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037227
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email rm-shiba@k7.dion.ne.jp

Sponsor
Institute National Hospital Organization Fukuoka Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.