None
Conditions
Interventions
Stachyose:Oral Stachyose
Sponsors
Changsha Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Ability to understand the nature of research and voluntarily sign informed consent forms; (2) Age >= 18 years old, male or female not limited; (3) There are no severe and/or uncontrolled diseases that the researchers have assessed as affecting clinical trials, including but not limited to: severe neurological disorders (such as epilepsy, dementia, etc.), severe history of mental disorders, major cardiovascular and cerebrovascular diseases, pulmonary hypertension, shock or persistent arrhythmia, heart failure, respiratory failure, etc; (4)There are no diseases that affect the metabolism and intestinal flora of patients, including but not limited to gastrointestinal system diseases, metabolic system diseases (such as diabetes, metabolic syndrome), autoimmune diseases, etc.
Exclusion criteria
Exclusion criteria: (1) Previously used stachyose for >= 1 month; (2) Use antibiotics within one month prior to screening; (3) Used probiotics and their preparations one week before screening; (4) Having undergone major surgery (including abdominal surgery) within the previous month prior to screening; (5) Positive pregnancy test results for women with fertility during the screening period; Pregnant or lactating women; (6) Allergic or intolerant to stachyose and pharmaceutical excipients; (7) Participants who have participated in any drug or medical device clinical trial within one month prior to signing the informed consent form are defined as those who have signed the informed consent form for the clinical trial and have used the investigational drug (excluding conventional treatment) or investigational medical device; Or if the participant is still within the follow-up period of a clinical study or within 5 half lives of the investigational drug (whichever is longer) before signing the informed consent form; (8) Have a history of drug abuse within 5 years prior to signing the informed consent form; (9) The researchers believe that there are any circumstances that may prevent the subjects from completing the study or pose significant risks to them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota;Serum metabolite; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function-ALT;Liver function-AST;Liver function-ALP;Liver function-GGT;Kidney function-Creatinine;Kidney function-uric acid;Kidney function-BUN; | — |
Countries
China
Contacts
Public ContactZhu Yingqun, Hong Peng
Changsha Third Hospital
Outcome results
None listed