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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005244
Receipt No. R000006236
Scientific Title Effect of synbiotics on oral immunotherapy for food allergy: a randomized study
Date of disclosure of the study information 2011/03/20
Last modified on 2016/09/20

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Basic information
Public title Effect of synbiotics on oral immunotherapy for food allergy: a randomized study
Acronym Synbiotics in oral immunotherapy for food allergy (SYNBOIT trial)
Scientific Title Effect of synbiotics on oral immunotherapy for food allergy: a randomized study
Scientific Title:Acronym Synbiotics in oral immunotherapy for food allergy (SYNBOIT trial)
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical efficacy and improvement of immunological markers of concurrent use of synbiotics in oral immunotherapy for food allergy. To collect preliminary data for large scale clinical trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Difference of achievement rate in immunotherapy between symbiotic group and control group.
Key secondary outcomes Occurrence and severity of adverse effect, change of biological marker.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Slow oral immunotherapy + synbiotics (1years)
Interventions/Control_2 Slow oral immunotherapy (1years)
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
5 years-old >=
Gender Male and Female
Key inclusion criteria 1) children (ages 1-5 years)
2) patients with immediate allergic reaction to egg or milk.
Key exclusion criteria Patients who have pronounced anaphylaxis shock.
Patients with severe symptoms with food challenge test.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Chiba University
Division name Department of pediatrics, Graduate School of Medicine,
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University
Division name Department of pediatrics, Graduate School of Medicine,
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL 043-226-2144
Homepage URL
Email

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Chiba Children's Hospital
Shimoshizu National Hospital
Kazusa DNA Research Institute
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 千葉大学医学部附属病院
千葉県立こども病院
国立病院機構下志津病院

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 20 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
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 14 Day
Last modified on
2016 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006236

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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