Chronic constipation
Conditions
Interventions
Study group:Subjects will take Lubiprostone capsules orally for 4 consecutive weeks, 24 µg per capsule, 1 capsule per dose, twice daily
Control group:Subjects will take lactulose solution orally for 4 consecutive weeks, starting with an initial dose of 30 mL per day. The maintenance dose will be 10-25 mL per day, administered orally,
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male and female subjects aged 65 years or older; 2) Meet the Rome IV criteria for the diagnosis of chronic constipation: I. Must include two or more of the following: - Straining during >25% of defecations; - Lumpy or hard stools in >25% of defecations; - Sensation of incomplete evacuation in >25% of defecations; - Sensation of anorectal obstruction/blockage in >25% of defecations; - Manual maneuvers to facilitate >25% of defecations; - Fewer than 3 spontaneous bowel movements per week; II. Loose stools are rarely present without the use of laxatives; III. Criteria for irritable bowel syndrome (IBS) are not met. All functional gastrointestinal disorders must meet the criteria that symptoms appear at least 6 months before diagnosis and have been present during the last 3 months. 3) Subjects are willing to discontinue the use of prescription and over-the-counter medications, traditional Chinese medicine, Chinese patent medicine, or dietary supplements used to treat constipation (except for emergency medications) during the screening, before treatment, during treatment, and for 2 weeks after treatment; 4) Subjects voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Suspected or confirmed organic abnormalities of the bowel (e.g., obstruction, stricture, malignancy), inflammatory bowel disease, or patients with megarectum/megacolon or pseudo-obstruction; 2) Patients who have undergone gastrointestinal/abdominal surgery within 90 days prior to enrollment; 3) Other conditions that, in the opinion of the investigator, make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour Spontaneous Bowel Movement (SBM) Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly SBM Response Rate;Time to First Spontaneous Bowel Movement (SBM);48-hour SBM Response Rate;Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency;Weekly Stool Consistency Score;Overall Treatment Effectiveness;Change from Baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) Score;Weekly Spontaneous Bowel Movement (SBM) Frequency; | — |
Countries
China
Contacts
Public ContactWang Lei
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed