UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028599 |
|---|---|
| Receipt number | R000032728 |
| Scientific Title | Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergy |
| Date of disclosure of the study information | 2017/08/09 |
| Last modified on | 2017/08/09 13:20:01 |
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Basic information
Public title
Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergy
Acronym
Phase I study for yoghurt therapy of filament Lactobacilus.
Scientific Title
Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergy
Scientific Title:Acronym
Phase I study for yoghurt therapy of filament Lactobacilus.
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of yoghurt feeding which made of a filament Lactobacillus by excessive consumption and long days consumption.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Blood test(TP, ALB, T-Bill, D-Bill, TTT, ZTT, GOT, GPT, ALP, LDH, GTP, ChE, LAP, CPK,AMY, T-CHO, HDL, LDL, TG, UA, BUN, CRE, Na, Cl , K, Ca, IP, Fe, Mg, TIBC)
, Urine test, IgE titter are going to compere before and after yoghurt consumption.
Key secondary outcomes
Observation harmful episodes during yoghurt consumptions.(Table CTCAA ver. 4)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Volunteer are going to make yoghurt with a filament Lactobacillus powder pack and soy milk 1000ml (Adjustment-free soy milk: Marusan) using the instrument for yoghurt (Yogurtia: Tanika)(40C,30h)on them own. Total 300ml yoghurt are taking a day divide 3 for 4weeks on Large volume yoghurt trial. 100ml yoghurt are taking a day for 3 months on extended period trial.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
Patient
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Fukunaga |
Organization
Shimane university, Faculty of Medicine
Division name
Department of Dermalogy
Zip code
Address
89-1, Enya-cho, Izumo, Shimane 693-8501 Japan
TEL
0853-20-2210
fukunagh@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Fukunaga |
Organization
Shimane university, Faculty of Medicine
Division name
Department of Dermalogy
Zip code
Address
89-1, Enya-cho, Izumo, Shimane 693-8501 Japan
TEL
0853-20-2210
Homepage URL
fukunagh@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Dermalogy
Shimane university, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reserch and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
島根大学医学部（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 10 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032728
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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