Human study for investigating the effectiveness and safety of Bacillus coagulans SNZ 1969 on intestinal microflora and defecation.
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002226
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Subject who voluntarily agrees to participate and sign in informed consent form
2) Adults (20 years= Age)
3) Subject who has defecation difficulty
- According to Rome III criteria(functional constipation)
1) Subject who has condition within 1 month as below
- Subject who has taken probiotics, prebiotics (dietary fiber, oligosaccharide) over 1 week consistently.
- Subject who takes antibiotics over 1 week consistently.
2) Recommended Food Score > 36
3) Subject who has symptoms as below or takes related drugs
- irritable bowel syndrome, functional bloating, functional diarrhea
- disease could cause of secondary constipation : hypothyroidism, improperly controlled diabetes, dementia, Parkinson's disease, mental illness(depressive disorder, anorexia nervosa), multiple sclerosis, traumatic vertebra injury, organic disturbance of colon, rectum, anus, pelvis (colorectal cancer, lesion of smooth muscle, rectocele, attenuation of fundus pelvis, intrarectal mucosal prolapse, full-thickness rectal prolapse, solitary rectal ulcer syndrome) etc.
- severe dysfunction of liver and kidney, alcoholism, cardiovascular disease (including hypertension), immune disease
4)Subject who has hypersensitivity to dietary supplement or ingredients contained in the supplement.
5)Subject who has been in clinical demonstration within 1 months.
6)Pregnant woman or lactating women
7)Subject who judged incongruent by tester through clinical examination center.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bowel habit
- Secondary Outcome Measures
Name Time Method Fecal microbiota