Unique ID issued by UMIN | UMIN000024654 |
---|---|
Receipt number | R000028363 |
Scientific Title | Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2016/10/31 |
Last modified on | 2018/06/21 10:07:16 |
Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Effects of fermented milk containing Bifidobacterium in healthy adults
Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Effects of fermented milk containing Bifidobacterium in healthy adults
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the efficacy of intake of fermented milk containing Bifidobacterium for 4 weeks in healthy adults.
Efficacy
Gastrointestinal symptoms at 4 weeks after ingestion of test sample
Psychological symptoms, Breath test, Salivary stress marker, QOL at 4 weeks after ingestion of test sample
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Fermented milk containing Bifidobacterium intake
Fermented milk not containing Bifidobacterium intake
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Healthy men and women aged from 20 to 64 years old.
2) 8 and over for modified FSSG score.
3) Subjects who understand details of the study and provides informed consent by documents.
1) Helicobacter pylori infection
2) Subjects who regularly use gastrointestinal drugs.
3) Functional Dyspepsia
4) Subjects who can't stop the ingestion of probiotics, prebiotics, foods containing lactic acid bacteria, bifidobacteria and other healthy foods which may affect gastrointestinal symptoms.
5) Subjects who have food allergy.
6) Subjects who have severe complication or serious diseases requiring an urgent treatment.
7) Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation.
8) Subjects who are judged as unsuitable for the study by the blood test results of screening test.
9) Subjects who are planning to become pregnant during the study or are pregnant or lactating.
10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
11) Subjects who are planning to participate or already participating in other clinical studies.
12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
100
1st name | |
Middle name | |
Last name | Yoshitaka Iwama |
Nihonbashi Cardiology Clinic
Director
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
yiwama@well-sleep.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Sales department
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Yakult Honsha Co.,Ltd
Profit organization
NO
2016 | Year | 10 | Month | 31 | Day |
Published
Completed
2016 | Year | 10 | Month | 07 | Day |
2016 | Year | 11 | Month | 05 | Day |
2016 | Year | 10 | Month | 31 | Day |
2018 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028363