Single center, double-blind, randomized, parallel trial to evaluate the efficacy of food containing yeast on human gastrointestinal functio
- Conditions
- Slight constipation
- Registration Number
- JPRN-UMIN000020476
- Lead Sponsor
- Prime Biz Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(1)Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders (2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment (3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system ( except appendectomy) (4)Subjects who suffer from diseases/ disorders that affects bowel movement such as irritable bowel syndrome or ulcerative colitis etc or have medical history of above-mentioned diseases/ disorders (5)Subjects with history of sensitivity to the ingredients (6)Pregnant, lactating women or willing to be pregnancy during the study (7)Subjects who take any kind of medicine ( laxative, intestinal drug etc) that possibly affect bowel movement (8)Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) regularly that possibly affect bowel movement (9)Subjects who have a habit of eating lactic fermenting beverage or food or Lactobacillus preparation that contain many lactobacillus, food fortified with dietary fiber and/or oligosaccharide 3 and more times per week (10)Any candidate considered to be unsuitable for enrollment based on his/her answers of life style questionnaire (11)Subjects who had participated in other clinical trials including drug and food within 1 month. (12)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency, defecation days(After intervention 11-12 weeks after)
- Secondary Outcome Measures
Name Time Method Amount of defection, fecal condition(form, color, smell, feeling after defecation)