constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for functional gastrointestinal disorders (Rome IV), and has a record of defecation frequency less than 3 times per week in the past three months. 2. Outpatient patients who need to undergo colonoscopy. 3. Aged between 18 and 75 years. 4. Confirmed to have no severe intestinal diseases (e.g., intestinal obstruction, intestinal tumors, etc.). 5. Voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic or local malignant tumors, or those who cannot discontinue immunosuppressants. 2. Patients with digestive system diseases that significantly affect the study: inflammatory bowel disease, infectious gastrointestinal disease, or some patients with intestinal polyps. 3. Patients with abnormal results of routine stool tests. 4. Patients with severe psychological or mental illnesses. 5. Patients with a history of drug abuse or alcohol abuse, or those who have consumed large amounts of alcohol or used antibiotics within the past month. 6. Patients allergic to the study drug. 7. Patients who cannot discontinue drugs, health products, or foods that cause diarrhea or affect intestinal flora during the trial, including: laxative Western medicines or Chinese patent medicines. 8. Patients who have undergone colonoscopy (or bowel preparation) within the past month. 9. Pregnant or lactating women. 10. Patients who are currently participating in other clinical trials, or who have completed other clinical trials for less than 3 months. 11. Patients with severe cardiac, hepatic, or renal insufficiency. 12. Other patients deemed unsuitable for enrollment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate after 14 days of medication: Improvement effect on defecation frequency and stool consistency; | — |
Secondary
| Measure | Time frame |
|---|---|
| gut microbiota sequencing;fecal calprotectin and serum zonulin; | — |
Countries
China
Contacts
Yuebei People’s Hospital