Constipation
Conditions
Interventions
Experimental group:Wanyi Blue WONDERLAB Yitong, specification: 40 billion/bottle, 2g/bottle. Dosage: Take twice a day, half an hour after breakfast and dinner, one bottle at a time, directly by mouth
Control group:WONDERLAB Placebo, specification: 2g/bottle Dosage: Take twice a day, half an hour after breakfast and dinner, one bottle at a time, directly oral or warm water below 37 degrees
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study, sign the informed consent form before the trial, and be able to complete the study in accordance with the requirements of the trial protocol; 2. Healthy male and female subjects over 50 years of age at the time of signing the informed consent; 3. Diagnosis of functional constipation according to Rome IV criteria; 4. Colonoscopy prompts within 1 year before screening (ileocecal part needs to be observed, and the ileocecal valve image needs to be recorded in the report): (1) The colonoscopy report is normal; (2) Abnormal colonoscopy reports, such as hemorrhoids, intestinal polyps (diameter 5mm or the number was >3, and the diameter of residual intestinal polyps after endoscopic treatment was <=5mm and the number was <=3, and the investigator judged that they could be enrolled. 5. Be able to understand the intervention process, and be clear about the purpose, benefits, possible risks and side effects of this study; 6. BMI between 18.5-24.9 kg/m^2; 7. Contraceptive Requirements: There is no contraceptive requirement for male subjects in this study; Female subjects participating in this study should be non-pregnant and not lactating. 8. During the trial, the subject agrees not to take other prebiotic/bacterial drugs, supplements or dairy products including yogurt drinks; 9. During the trial, the subject agrees not to participate in other clinical studies;
Exclusion criteria
Exclusion criteria: 1. Within 30 days prior to the subject's screening visit, have taken medications, dietary supplements, or any food that has been added or contains substances, bacteria, or yeast that may have an impact on the primary and secondary outcomes; 2. Presence of acute infection at the screening visit; 3. Subjects who have used any oral or intravenous antibiotic intervention within 30 days prior to the screening visit, or who may need to use antibiotics during the trial; 4. During the trial, it is impossible to stop drugs that can affect the movement and function of the gastrointestinal tract, including drugs that regulate the intestinal microecology (such as bifidobacteria), drugs that inhibit gastric acid secretion, etc. 5. Suspected presence of obstructive intestinal obstruction or previous suspected or confirmed obstructive intestinal obstruction. 6. Subject has organic diseases known to affect intestinal function: such as a history of gastrointestinal surgery, including bariatric surgery; Malignant gastrointestinal tumors, inflammatory bowel disease (IBD), hyperthyroidism or hypothyroidism, Hirschsprung's disease, etc.; 7. Subjects using opioid analgesics 8. Previous colonoscopy or sigmoidoscopy showing clinically significant abnormalities; 9. Significant abnormalities in laboratory examinations, and the investigator's judgment that the subject's participation in this study may harm its safety, including but not limited to: (1) Creatinine >=1.5 times the upper limit of normal (ULN); (2) AST>=2 times the upper limit of normal (ULN) and/or ALT>=2 times the upper limit of normal (ULN) and/or total bilirubin >=1.5 times the upper limit of normal (ULN) (3) Platelets are less than the lower limit of normal (LLN); 10. The stool examination results show occult blood (+) and (+) or white blood cells (+) and (+) and (+) and are judged by the investigator to be clinically significant (except for cases caused by hemorrhoids or female menstrual period) 11. Subjects with diabetes mellitus; 12. Subject has a habit of drinking, drinking more than three glasses of wine per day or two glasses of 25 ml beer per day, or one glass of spirits per day; 13. Life expectancy less than 12 months; 14. Presence of psychiatric disorders that affect the assessment of results, or current use or use of medications including antidepressants, antiepileptic drugs, antihistamines, antiparkinsonians, and antipsychotics that may affect bowel habits within 30 days prior to the screening period; 15. Known or suspected allergy to the components of this investigational product; 16. Presence of lactose intolerance 17. The subject has gastrointestinal, liver, kidney, endocrine, hematologic, respiratory and other related diseases that affect the safety evaluation and efficacy evaluation of the subject; 18. During the trial, the subject and his or her partner are unable or unwilling to use reliable contraceptive measures for contraception, or the female or male partner of the subject has recently planned to become pregnant; 19. Any other situation or condition that, in the opinion of the investigator, is not suitable for the subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of complete spontaneous bowel movement (CSBM); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pittsburgh Sleep Quality Index;Change in the number of completely spontaneous bowel movements per week;Change in spontaneous bowel movements per week;Change in colonic transit time; | — |
Countries
China
Contacts
Public ContactLishu Xu
Guangdong Provincial People's Hospital
Outcome results
None listed