Unique ID issued by UMIN | UMIN000035202 |
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Receipt number | R000040114 |
Scientific Title | Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study |
Date of disclosure of the study information | 2018/12/10 |
Last modified on | 2019/11/06 11:02:29 |
Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study
Study of the effect of a drink containing lactic acid bacteria on bowel movement,intestinal flora and fecal properties in subjects with constipation tendency.
Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study
Study of the effect of a drink containing lactic acid bacteria on bowel movement,intestinal flora and fecal properties in subjects with constipation tendency.
Japan | South America |
Healthy adult
Adult |
Others
NO
This study aimed to verify the effect of drink containing lactic acid bacteria on bowel movement, fecalproperties in subjects with constipation tendency for 2 weeks.
Efficacy
Defecation frequency
Evaluate two weeks after starting ingestion.
Defecation days, Fecal amount, Fecal properties. Intestinal flora(Real-Time PCR). Fecal moisture. Fecal pH. The fecal concentrations of ammonia.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of test product for 2 consecutive weeks
Ingestion of placebo for 2 consecutive weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1)males and females from 20 to 64 years of age
(2)Subjects who answered that the usual defecation frequency was 5 or less per week in the questionnaire
(3)Subjects with constipation tendency and lower defecation frequency during screening period
(1)Subjects who cannot restrict the use of medicines or health foods that may influence their bowel movements after informed consent
(2)Subjects visiting the hospital for diseases related bowel movements and using drugs, or are regularly using commercially available constipation medicine
(3)Subjects currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy)
(4)Subjects with diseases (irritable enteritis, ulcerative colitis,etc.) affecting bowel movement or have a history of these diseases
(5)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(7)Subjects have a deseases requiring regular medication or a history of serious diseases for which medication was required
(8)Subjects have possibilities to develop an allergy to the test product
(9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(11)Subjects who have participated in other clinical studies
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(13)Subjects judged as unsuitable for the study by the investigator for other reasons
100
1st name | |
Middle name | |
Last name | Jiro Saito |
Medical Station Clinic
None
3-12-8 Takabann, Meguro-ku, Tokyo, Japan
03-6452-2712
info@med-station.jp
1st name | |
Middle name | |
Last name | Chiharu Goto |
TTC Co., Ltd.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
03-5459-5329
c.goto@ttc-tokyo.co.jp
TTC Co., Ltd.
Nissin York Co.,Ltd.
Profit organization
NO
2018 | Year | 12 | Month | 10 | Day |
Unpublished
Completed
2018 | Year | 11 | Month | 22 | Day |
2018 | Year | 11 | Month | 22 | Day |
2018 | Year | 12 | Month | 11 | Day |
2019 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 10 | Day |
2019 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040114
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