UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030379 |
|---|---|
| Receipt number | R000034386 |
| Scientific Title | Randomized double-blind comparative study on the effect of bifidobacteria on the induction of resistance to hen's egg allergy oral immunotherapy |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/01/16 13:02:50 |
* 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
Randomized double-blind comparative study on the effect of bifidobacteria on the induction of resistance to hen's egg allergy oral immunotherapy
Acronym
Randomized double-blind comparative study on the effect of bifidobacteria on the induction of resistance to hen's egg allergy oral immunotherapy
Scientific Title
Randomized double-blind comparative study on the effect of bifidobacteria on the induction of resistance to hen's egg allergy oral immunotherapy
Scientific Title:Acronym
Randomized double-blind comparative study on the effect of bifidobacteria on the induction of resistance to hen's egg allergy oral immunotherapy
Region
| Japan |
Condition
Condition
hen's egg allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Randomly allocate to hen's egg allergy patients who do not acquire natural tolerance to oral administration group of bifidobacteria daily and placebo (dextrin) daily oral administration group. In addition, the oral immunotherapy of the same protocol is carried out in both groups, and the situation of acquiring the tolerance of the two groups is compared, and the purpose is to verify the resistance inducing effect of Bifidobacterium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acquisition rate of egg tolerance at 52 weeks after intervention started
Key secondary outcomes
Egg tolerance acquisition rate at 48 weeks after intervention started
Objective indicator (blood: change in eosinophil count, total IgE, antigen specific IgE (egg egg: 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, 52weeks
Interventions/Control_2
dexistrin , twice a day, 52weeks
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Obvious hen's egg allergic patients
b) Patients who are 5 years or older 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 the 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, 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
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Imai |
Organization
Showa University
Division name
Department of Pediatrics
Zip code
Address
1-5-8hatanodai, shinagawa-ku, tokyo, Japan
TEL
03-3784-8000
ta-imai@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Imai |
Organization
Showa University
Division name
Department of Pediatrics
Zip code
Address
1-5-8hatanodai, shinagawa-ku, tokyo, Japan
TEL
03-3784-8000
Homepage URL
ta-imai@med.showa-u.ac.jp
Sponsor or person
Institute
showa university
Institute
Department
Personal name
Funding Source
Organization
self procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2018 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
