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 |
Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergy
Phase I study for yoghurt therapy of filament Lactobacilus.
Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergy
Phase I study for yoghurt therapy of filament Lactobacilus.
Japan |
Food allergy
Clinical immunology | Dermatology | Adult |
Others
NO
Safety evaluation of yoghurt feeding which made of a filament Lactobacillus by excessive consumption and long days consumption.
Safety
Confirmatory
Explanatory
Phase I
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.
Observation harmful episodes during yoghurt consumptions.(Table CTCAA ver. 4)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
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.
20 | years-old | <= |
Not applicable |
Male and Female
healthy person
Patient
12
1st name | |
Middle name | |
Last name | Hajime Fukunaga |
Shimane university, Faculty of Medicine
Department of Dermalogy
89-1, Enya-cho, Izumo, Shimane 693-8501 Japan
0853-20-2210
fukunagh@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Hajime Fukunaga |
Shimane university, Faculty of Medicine
Department of Dermalogy
89-1, Enya-cho, Izumo, Shimane 693-8501 Japan
0853-20-2210
fukunagh@med.shimane-u.ac.jp
Department of Dermalogy
Shimane university, Faculty of Medicine
Japan Agency for Medical Reserch and Development
Japanese Governmental office
Japan
NO
島根大学医学部(島根県)
2017 | Year | 08 | Month | 09 | Day |
Unpublished
No longer recruiting
2016 | Year | 09 | Month | 26 | Day |
2016 | Year | 10 | Month | 10 | Day |
2017 | Year | 08 | Month | 09 | Day |
2017 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032728