Human study to evaluate the effectiveness and safety of 'Lactomin Plus' on the improvement of bowel functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007564
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
When adult men and women complaining of intestinal discomfort due to diarrhea consumed 12 g of lactomin plus per day for 8 weeks, the frequency of bowel movements and satisfaction with normal bowel movements were significantly increased from the 4th week compared to the control group. In the case of the intestinal flora, it was confirmed that Lactobacillales at the class level, Bacilli at the class level, and Streptococaceae at the family level increased compared to before intake, and these strains are considered to have contributed to the improvement of the intestine. In terms of safety, it was found to be safe as a result of evaluating vital signs, clinical blood and urine tests, and adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
1) Subjects who voluntarily agree to participate and sign informed consent forms
2) Adults (20 = age < 65 years)
3) Subjects who have bad bowel movement
4) Subjects who have positive fecal calprotectin level
1) Subject who consumes probiotics, prebiotics or antibiotics over 1 week consistently within 1 month
2) Subject who consumes high dietary fiber
3) Subject who has other underlying disease in digestive system currently or within two years
4) Subject who has intestinal surgery
5) Subject who has lactose intolerance
6) Subject who has diseases described below or takes related drugs:
- severe liver disease, renal dysfunction, cardiovascular disease, immunological diseases and malignant tumors, etc
7) Subject who took the antiepileptic or antidiarrheal drugs within three days of his first visit
8) In the case of trip to area with epidemic parasitic diseases recently
9) Subject who has hypersensitivity to test food or ingredients of test food
10) Subject who has been in clinical trial within 1 month
11) Pregnant or lactating women or person who has pregnancy plan during the study
12) Any condition that the principal investigator believes may put the subjects at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fecal analysis
- Secondary Outcome Measures
Name Time Method Intestine symptom survey;Clinical pathological examination (blood test and urine test);Vital signs;Adverse event