UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033739 |
|---|---|
| Receipt number | 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 | 2022/08/23 12:55:45 |
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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 | Mayu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University
Division name
Department of pediatrics
Zip code
142-8666
Address
1-5-8 hatanodai, shinagawa-ku, Tokyo, Japan
TEL
0337848000
mayu-shimi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University
Division name
Department of Pediatrics
Zip code
142-8666
Address
1-5-8 hatanodai, shinagawa-ku, Tokyo, Japan
TEL
0337848000
Homepage URL
mayu-shimi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University, Department of pediatrics
Institute
Department
Personal name
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
Showa University Hospital Institutional Review Board
Address
1-5-8 hatanodai, shinagawa-ku, Tokyo, Japan
Tel
0337848000
mayu-shimi@med.showa-u.ac.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
| 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
48
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 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038479
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