Chronic idiopathic constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old (including the critical value), male and female; (2) <3 spontaneous defecations per week (spontaneous defecation is defined as defecation without the use of laxatives, suppositories, or enemas in the past 24 hours), and at least one of the following symptoms has occurred during at least 25% of defecations in at least 12 weeks (not necessarily consecutive) within the past 6 months: Exertion, the need for manual assistance, lumpy or hard stools, and incomplete emptying; (3) No special colonoscopy and other auxiliary examinations within 1 year.
Exclusion criteria
Exclusion criteria: (1) Patients with severe heart and cerebrovascular diseases, connective tissue diseases, Parkinson's disease, spinal cord injury, and severe liver and kidney insufficiency; (2) Those who are intolerant or allergic to the experimental drug; (3) Patients with confirmed digestive tract tumors or other advanced system tumors; (4) Women who have positive pregnancy tests or have pregnancy plans and breastfeeding women; (5) Those who cannot cooperate with disease examination and treatment; (6) Patients with a history of abdominal surgery, diabetes and inflammatory bowel disease; (7) Within 30 days before the start of the trial, tricyclic antidepressants, antibiotics, mototropic drugs, laxatives other than the prescription of serol, probiotics, etc., had been used with the same mechanism of action as the study drugs; (8) Constipation is secondary to other diseases (such as severe liver dysfunction, anxiety and depression, metabolic diseases, malignant tumors, renal dysfunction, endocrine diseases) or interventions in the past 5 years (such as drugs);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool flora 16s sequencing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Constipation symptom;Constipation Patients Quality of Life Scale (PAC-QOL);Wexner rating Scale; | — |
Countries
China
Contacts
Shandong Provincial Hospital