Functional constipation
Conditions
Interventions
Experimental group:Lutropin alpha capsules, 24µg per capsule, 1 capsule at a time, taken twice a day, with breakfast and dinner, accompanied by food and water, to be swallowed whole, not to be split o
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent; 2. No gender restrictions, ages 18-75 (including 18 years old); 3. Meet the Rome IV criteria for Functional Constipation (FC) (see Appendix 1); 4. Spontaneous bowel movement frequency less than 3 times per week for 2 weeks prior to medication administration; 5. Able to complete the subject log and research questionnaire according to the trial protocol; 6. Agree to take effective contraceptive measures from the signing of the informed consent to 3 months after the last dose of the trial medication.
Exclusion criteria
Exclusion criteria: 1. Failure to sign the informed consent form; 2. Pregnant or breastfeeding women, or women preparing to become pregnant or breastfeeding during the study, or male subjects whose female partners are pregnant, or female partners of male subjects preparing to become pregnant during the study; 3. History of using lubiprostone; 4. Allergic to lubiprostone and its excipients or glycerin enema; 5. Patients with IBS-C who meet the Rome IV diagnostic criteria; 6. Contraindicated for those with known or suspected mechanical intestinal obstruction; 7. Patients with megacolon/megarectum;Patients with a clearly diagnosed organic gastrointestinal disease, such as pancreatitis, inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (polyps =14.30 days excluded), multiple diverticula (single small diverticulum with a diameter less than 0.5 cm excluded), intestinal tumors, etc.; 8. Patients with constipation caused by secondary reasons (drugs, diabetes, hypothyroidism, depression, etc.); 9. History of gastrointestinal or abdominal surgery within 3 months prior to the screening (excluding polypectomy by colonoscopy, see exclusion criteria point 9); 10. Severe cardiovascular, liver, respiratory, urogenital, endocrine system, autoimmune diseases, neurological, mental disorders (including mental disorders caused by alcohol and drug abuse), immune deficiency diseases, as deemed unsuitable by the investigator; 11. History of malignant tumors within 5 years prior to screening; 12. Clinically significant abnormalities in laboratory tests that the investigator deems unsuitable for participation in the study, including: (1) Cr above the upper limit of normal; (2) ALT and/or AST > 2 times the upper limit of normal (ULN); (3) TBIL >= 1.5 times the upper limit with AST/ALT above the upper limit of normal (ULN); (4) Fasting blood glucose >= 7.0 mmol/L; 13. Cannot stop or plan to use medications affecting gastrointestinal motility and function from signing the informed consent to the end of the observation period, such as prokinetics, anticholinergics, calcium channel blockers, secretory laxatives, other gastrointestinal prokinetics, traditional Chinese medicine, Chinese patent medicines, intestinal lubricants and weight loss tea, 5-HT3 receptor antagonists, antidepressants, anxiolytics, intestinal microbiome regulators, and antibiotics, etc.; 14. Subjects who participated in any clinical trial and received treatment in the past 3 months; 15. History of drug or alcohol abuse within 1 year prior to screening; 16. Planning to become pregnant or unwilling to take reliable contraceptive measures during the study within 4 weeks after signing the informed consent until the last intake of the trial drug; 17. Unable to comply with the trial protocol; 18. Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of spontaneous bowel movements (SBM) at the beginning of treatment for one week; | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of spontaneous bowel movements (SBM) ;Time of first spontaneous bowel movement (SBM);Proportion of patients with spontaneous bowel movements (SBM) within 24 hours of first administration; | — |
Countries
China
Contacts
Public ContactChengdang Wang
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed