UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037482 |
|---|---|
| Receipt number | R000042731 |
| Scientific Title | Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy |
| Date of disclosure of the study information | 2019/07/25 |
| Last modified on | 2021/01/25 09:21:24 |
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Basic information
Public title
Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Acronym
Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG
Scientific Title
Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Scientific Title:Acronym
Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for children with severe food allergy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained unresponsiveness to middle dose after 12 months.
Middle dose was defined as half of the whole egg, 25ml of cow's milk, 25g of udon noodle (Japanese wheat noodle), 3g of peanuts, or 3g of nuts.
Key secondary outcomes
Intestinal microbiota
Short-chain fatty acids (acetic acid, butyric acid, propionic acid, valeric acid) in the serum
Changes in specific IgE, IgG, and IgG4 titer
Frequency of adverse reactions during therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients consume Lactobacillus rhamnosus GG during the oral immunotherapy for 1 year.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who reacted to low-dose oral food challenge.
Low-dose was defined as 'one eighth of the whole egg, 3 ml of cow's milk, 2 g of udon noodle (Japanese wheat noodle), 0.5 g of whole peanuts, or 0.5 g of nuts.'
Key exclusion criteria
Decision of ineligibility by a physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Miura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
yoko6299@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Technical Research Laboratory Takanashi Milk Products Co. Ltd. Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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 | 07 | Month | 25 | 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
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042731
