Unique ID issued by UMIN | UMIN000015338 |
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Receipt number | R000017837 |
Scientific Title | Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study |
Date of disclosure of the study information | 2014/10/03 |
Last modified on | 2015/04/06 13:09:40 |
Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study
Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora
Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study
Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora
Japan |
Subjects with a tendency for constipation
Not applicable |
Others
NO
Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora of adults with a tendency for constipation.
Efficacy
Defecation frequency, defecation days, intestinal microflora
Stool output, fecal condition, quantitative analysis of intestinal microflora (total anaerobes, Bifidobacterium, Clostridium perfringens), fecal water content, fecal pH
Interventional
Parallel
Non-randomized
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of lactic acid bacteria beverage containing Lactobacillus plantarum LP14 for 2 weeks
Ingestion of placebo beverage without Lactobacillus plantarum LP14 for 2 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Males and females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week
(1) Subjects regularly using drugs (constipation drugs, intestinal drugs, etc.)
, health foods (senna tea, kefir, etc.), or foods for specified health use (indigestible dextrin, chitosan, oligosaccharides, etc.)
(2) Subjects having a large amount of foods such as lactic acid bacteria beverage, food containing lactic acid bacteria (yogurt, kimchi, pickles, sushi fermented with fish and vegetables, etc.), lactic acid bacteria preparation, dietary fiber enriched food, and oligosaccharides more than three times a week
(3) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative
(4) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
(5) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
(6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(8) Subjects having possibilities for emerging allergy related to the study
(9) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(10) Subjects who have participated in other clinical studies
(11) Subjects who intend to become pregnant or lactating
(12) Subjects judged as unsuitable for the study by physician for other reasons
60
1st name | |
Middle name | |
Last name | Manabu Shizume |
Shizume Kinen Clinic
internal medicine
2-16-7 Yoyogi, Shibuya-ku, Tokyo
03-3299-3591
shizumechiken@yahoo.co.jp
1st name | |
Middle name | |
Last name | Mika Watanabe |
TTC Co., Ltd.
Clinical Research Planning Department
1-20-2 Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
m.watanabe@ttc-tokyo.co.jp
TTC Co., Ltd.
Nissin Foods Holdings CO., LTD.
Profit organization
NO
2014 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 10 | Month | 02 | Day |
2014 | Year | 10 | Month | 03 | Day |
2015 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017837
Research Plan | |
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