None listed
Conditions
Interventions
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
75 Years to 105 Years
Inclusion criteria
Inclusion criteria: 1. Elderly persons with full capacity for civil conduct, aged >= 75 years, male or female; 2. Male weight >= 50 kg, female weight >= 45 kg; body mass index (BMI) = weight (kg)/height^2 (m^2) in the range of 19.0-27.0 (including upper and lower limits); 3. Voluntarily participate in the study and sign the informed consent and agree to follow the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. History of needle-sickness and blood sickness; 2. History of diseases or new diseases that may affect the study within the past 1 month: (1) Diseases affecting intestinal P-gp: severe diarrhea (more than 3 excretions per day with watery stools), Crohn's disease, ulcerative colitis, irritable bowel syndrome, Diverticulitis, Clostridium difficile infection (recurrent), or Helicobacter pylori infection; (2) Diseases that affect changes in gut flora: non-alcoholic fatty liver disease, diabetes; (3) Diseases affecting liver CYP3A activity: acute kidney injury, liver cirrhosis, liver abscess, liver cancer, intrahepatic bile duct stones, etc.; 3. Major disease history or new occurrence: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia, etc.; 4. Use of drugs that may affect the study in the past 1 week: (1) Drugs that affect gut microbiota: continuous use of antibiotics, bifidobacterium triplex live powder, lactobacillin tablets, compound Lactobacillus acidophilus tablets, bacillus subtilis triplex live intestinal capsule, etc.; (2) Drugs affecting intestinal P-GP/3A activity: potent P-GP/3A inhibitor, inducer; 5. Renal function: creatinine clearance CRCL = 100 mL of high-alcohol liquor), about 2 taels/ 200 mL wine/ 600 mL beer); 7. History of gastrointestinal surgery such as gallbladder or appendectomy and bariatric surgery within the last five years; 8. Virology test (positive for human immunodeficiency virus antibody (HIV-AB), syphilis serological test, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCV-AB) within 3 months prior to screening; 9. Those who participated in clinical trials of any drug or medical device within 3 months before screening, or those who were within 5 half-life of the drug before screening (the half-life of the test drug is long, 5 half-life is more than 3 months), are judged by the investigator to be not suitable for this study; 10. Subjects with any factors that the investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota; | — |
Countries
China
Contacts
Public ContactLiu Dongyang
Peking University Third Hospital
Outcome results
None listed