![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037482 |
Receipt No. | 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 | 2019/07/25 |
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 |
|
Condition | ||
Condition | food allergy | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
Institute | National Hospital Organization Sagamihara National Hospital |
Institute | |
Department |
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 |
furuta.harumi.we@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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042731 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |