Healthy subjects
Conditions
Interventions
Single intake of the probiotics food
Single intake of the placebo food
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cases undergoing colonoscopy for the purpose of further examination of positive fecal occult blood test, screening, follow-up after endoscopic treatment of colorectal tumors, or for endoscopic treatment of colorectal tumors. 2) Performance Status (ECOG scale): Cases with a score of 0 to 2. 3) Age: Cases aged 20 years or older but under 65 years at the time of registration. 4) Cases with preserved major organ functions and the following bone marrow, liver, and kidney functions: 1 Hemoglobin: 8.0 g/dL or higher 2 White blood cell count: 3,500/mm3 or higher but less than 12,000/mm3 3 Platelet count: 100,000/mm3 or higher 4 Total bilirubin: 1.5 mg/dL or less 5 AST (GOT) and ALT (GPT): 100 IU/L or less 6 ALP: 2 times or less the upper limit of the institution's standard value 7 Creatinine (CRE): Less than 1.5 mg/dL 5) Cases capable of oral intake. 6) Cases from whom written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1) Individuals who are using proton pump inhibitors (PPI), vonoprazan (P-CAB), or other gastric acid secretion inhibitors, cholesterol absorption inhibitors, antidiabetic drugs, antihypertensive drugs, antibiotics, antithrombotic drugs, or probiotics and cannot discontinue these medications during the study period. 2) Individuals who cannot discontinue the intake of specific health foods, functional foods, nutritional functional foods, or foods and supplements containing Bifidobacterium during the study period. 3) Individuals with a history of drug or food allergies. 4) Individuals who are pregnant, intend to become pregnant during the study period, or are breastfeeding. 5) Individuals who plan to travel abroad or have overseas travel plans during the study period. 6) Individuals who have participated in other studies involving the intake of foods or drugs, or the application of cosmetics or drugs within the past 4 weeks, are currently participating, or intend to participate. 7) Other cases deemed inappropriate by the physician for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of Bifidobacterium in the ileal microflora | — |
Secondary
| Measure | Time frame |
|---|---|
| Ileal microbiota analysis, pH and metabolome analysis such as short-chain fatty acids and bile acids, proteome analysis | — |
Countries
Japan
Contacts
Public ContactKen Inoue
Kyoto Prefectural University of Medicine Gastroenterology
Outcome results
None listed