Unique ID issued by UMIN | UMIN000029289 |
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Receipt number | R000033435 |
Scientific Title | Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children |
Date of disclosure of the study information | 2017/10/02 |
Last modified on | 2019/04/05 11:18:31 |
Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Evaluation of effects of formulas containing oligosaccharides on the fecal microflora of young children
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To evaluate effects of formulas containing oligosaccharides on the fecal microflora.
Safety,Efficacy
Fecal microflora analysis
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
3
Prevention
Food |
Intake of the formula containing oligosaccharide (500mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
Intake of the formula containing oligosaccharide (1000mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
Intake of the placebo formula (0mg oligosaccharide/100g of milk powder, 56g of milk powder/day, 4 weeks)
12 | months-old | <= |
34 | months-old | >= |
Male and Female
1) Children aged 12-34 months
2) Obtained written informed consent from the parents
3) Subjects who are judged appropriate for the study by the investigator
1) Subjects with food allergy
2) Breast-fed children at study entry
3) Diagnosed as having liver, renal, cardiovascular, lung, GI, blood or metabolic disease
4) Subjects who participate another study
5) Subjects who are judged inappropriate for the study by the investigator
60
1st name | Takashi |
Middle name | |
Last name | Koikeda |
Shiba Palace Clinic
Hospital director
105-0013
6F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
03-5408-1599
jimukyoku@mail.souken-r.com
1st name | Miwa |
Middle name | |
Last name | Kaneko |
SOUKEN Co., Ltd.
Secretariat
105-0013
3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
03-5408-1555
m_kaneko@mail.souken-r.com
SOUKEN Co., Ltd.
Morinaga Milk Industry Co.,Ltd.
Profit organization
Shiba Palace Clinic Research Ethics Committee
3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
03-5408-1599
jimukyoku@mail.souken-r.com
NO
2017 | Year | 10 | Month | 02 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 20 | Day |
2017 | Year | 09 | Month | 14 | Day |
2017 | Year | 10 | Month | 24 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 06 | Month | 21 | Day |
2018 | Year | 06 | Month | 22 | Day |
2018 | Year | 07 | Month | 31 | Day |
2017 | Year | 09 | Month | 26 | Day |
2019 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033435
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