Unique ID issued by UMIN | UMIN000027305 |
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Receipt number | R000031289 |
Scientific Title | Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study |
Date of disclosure of the study information | 2017/05/15 |
Last modified on | 2018/11/19 11:57:34 |
Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Low dose of lactulose for intestinal function
Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Low dose of lactulose for intestinal function
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To research effect of 2 g lactulose for intestinal function.
Efficacy
Confirmatory
Feces frequency
Defecation number of days, Feces hardness, Volume of feces
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Central registration
2
Treatment
Food |
Intake of lactulose 2g/day for 2weeks
Intake of placebo for 2weeks
18 | years-old | <= |
65 | years-old | > |
Male and Female
1) Subjects with feces frequency 2-4 times / week
1) Subjects with severe hepatic, renal, heart, gastrointestinal, cerebrovascular, endocrine, metabolic or infection diseases.
2) Subjects with the history of gastrointestinal resection.
3) Subjects with gastrointestinal dysfunction such as irritable bowel syndrome or inflammatory bowel disease.
4) Subjects who use medicines or supplements that may influence feces frequency; e.g. antibiotics, probiotics, laxatives, antidiarrheals, fibers.
5) Subjects with milk allergy.
6) Subjects with lactose intolerance
7) Subjects who participate another study.
8) Subjects who are judged inappropriate for the study by the investigator or the physician.
60
1st name | |
Middle name | |
Last name | Hisakazu Iino |
Showa Women's University
Graduate School, Science for Living System
1-7-57 Taishido, Setagaya-ku, Tokyo
03-3411-4828
iino@swu.ac.jp
1st name | |
Middle name | |
Last name | Hisakazu Iino |
Showa Women's University
Graduate School, Science for Living System
1-7-57 Taishido, Setagaya-ku, Tokyo
03-3411-4828
iino@swu.ac.jp
Showa Women's University
Morinaga Milk Industry Co., LTD.
Profit organization
NO
2017 | Year | 05 | Month | 15 | Day |
Unpublished
Completed
2017 | Year | 04 | Month | 08 | Day |
2017 | Year | 05 | Month | 15 | Day |
2017 | Year | 12 | Month | 07 | Day |
2018 | Year | 04 | Month | 11 | Day |
2018 | Year | 06 | Month | 13 | Day |
2018 | Year | 07 | Month | 30 | Day |
2017 | Year | 05 | Month | 11 | Day |
2018 | Year | 11 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031289
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