None
Conditions
Interventions
Daily ingestion of lactulose for 4 weeks.
Daily ingestion of placebo for 4 weeks.
Sponsors
KSO corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Healthy males and females who are aged 18-64 years at the time of obtaining consent. 2 Subjects who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1 Subjects undergoing treatment for serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases. 2 Subjects with a history of surgery on their digestive tract (excluding adenoidectomy, appendicitis, etc.). 3 Subjects with gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease. 4 Subjects who regularly take medicine that affects intestinal environment. 5 Subjects who regularly take foods with function claims, foods for specified health uses or supplements that affect intestinal environment. 6 Subjects with serious allergies to drugs or foods, or those with a history of them. 7 Subjects with milk allergy 8 Subjects with lactose intolerance. 9 Pregnant or breastfeeding women or women who expect to become pregnant during this study. 10 Subjects who consume more than 60 g of pure alcohol per day. 11 Subjects with a smoking habit. 12 Subjects who have participated in other clinical trials within 3 months of consent or who plan to participate in other clinical trials during this study period. 13 Subjects who are judged ineligible to this study by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota (Relative abundance of bifidobacteria) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed