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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033739
Receipt No. R000038479
Scientific Title Randomized double-blind comparative study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.
Date of disclosure of the study information 2018/08/15
Last modified on 2020/02/13

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Basic information
Public title Randomized double-blind comparative study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.
Acronym Study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.
Scientific Title Randomized double-blind comparative study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.
Scientific Title:Acronym Study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.
Region
Japan

Condition
Condition Hen's egg allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Low-dose oral immunotherapy is performed to infant with egg allergy.
These participants are randomly divided into bifidobacteria group and placebo(dextrin) group. The bifidobacterial group daily receive bifidobacteria, while the placebo group daily receive dextrin during treatment.
In this study, we investigated the efficacy of bifidobacteria at low-dose OIT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of 1/8 hen's egg tolerance at 32 weeks after intervention started
Key secondary outcomes The rate of 1/32 hen's egg desensitization at 32 weeks after intervention started.
Objective indicater(blood:change in eosinophil count,total IgE,antien specific IgE(egg white,egg yolk,ovomucoid),antigen specific IgG4(egg white,ovomucoid),basophil stimulation test(OVM), faeces:intestinal flora, calprotectin,skin prick test)
Side reaction rate on oral immunotherapy,
Safety assessment(incidence of adverse events)

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 NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Bifidobacteria, twice a day, 42 weeks
Interventions/Control_2 Dextrin, twice a day, 42 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
2 years-old <=
Age-upper limit
5 years-old >=
Gender Male and Female
Key inclusion criteria a) Obvious hen's egg allergic patients
b) Patients who are 2 years or older and 5 years or younger at the start of the study
c) After receiving sufficient explanation for the participation of this study, patients who obtained document consent with the free will of the patient himself or substitute person with sufficient understanding
Key exclusion criteria a) Of control poor atopic dermatitis or bronchial asthma
b) Cardiovascular, cranial nerve, Renal urology, Hepatobiliary, pancreatic, gastrointestinal, etc, which are serious or have diseases which may affect research
c) Implementing other immunotherapy
d) Other test responsibilities(shared) patients judged inappropriate by the doctor as subjects
Target sample size 68

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayu Maeda
Organization Showa University
Division name Department of pediatrics
Zip code
Address 1-5-8 hatanodai, shinagawa-ku, Tokyo, Japan
TEL 0337848000
Email mayu-shimi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayu Maeda
Organization Showa University
Division name Department of Pediatrics
Zip code
Address 1-5-8 hatanodai, shinagawa-ku, Tokyo, Japan
TEL 0337848000
Homepage URL
Email mayu-shimi@med.showa-u.ac.jp

Sponsor
Institute Showa University, Department of pediatrics
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JPN

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

Other administrative information
Date of disclosure of the study information
2018 Year 08 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 15 Day
Date of IRB
2018 Year 02 Month 05 Day
Anticipated trial start date
2018 Year 02 Month 15 Day
Last follow-up date
2022 Year 12 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
2018 Year 08 Month 13 Day
Last modified on
2020 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038479

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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