Chronic constipation
Conditions
Interventions
Chronic constipation observation group:None
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for this study: 1. Male or female, aged between 18 and 80 years (inclusive); 2. Must meet the Rome IV criteria for functional constipation; I. Must include one or more of the following: a. >25% of the time experiencing difficulty in defecation; b. >25% of the time having dry or hard stools; c. >25% of the time feeling incomplete defecation; d. >25% of the time experiencing a sensation of anal-rectal obstruction (or blockage); e. >25% of the time requiring manual assistance for defecation; f. Less than 3 spontaneous defecations per week; II. Rarely have loose stools without the use of laxatives; III. Do not meet the diagnostic criteria for irritable bowel syndrome. All functional gastrointestinal disorders must have had the onset of symptoms for at least 6 months before diagnosis, and must meet the symptom requirements within the last 3 months. 3. Able to fill out the study follow-up log card and study scales as required.
Exclusion criteria
Exclusion criteria: Potential patients who meet any of the following criteria will be excluded: 1. Those suspected or diagnosed with organic abnormalities in the intestines (obstruction, stenosis, cancer), inflammatory bowel diseases, megacolon/megacystis, or pseudo-obstruction; 2. Patients with a history of abdominal or pelvic surgery within the last 3 months (except for patients who have had polyp removal via colonoscopy); 3. Those who have previously used or are currently receiving lubiprostone treatment for >= 1 week; 4. Pregnant or lactating women or those planning to become pregnant or breastfeed during the observation period; 5. Patients assessed by the researcher as not suitable for inclusion in the observation, including: a. Those with abnormal liver function as determined by laboratory tests, and the researcher deems them unsuitable for inclusion in the observation, including ALT and/or AST > 2 times the upper limit of normal (ULN), TBIL >= 1.5 times the ULN with ALT/AST higher than the ULN; b. Those diagnosed with severe cardiovascular system, liver, respiratory system, urinary system, nervous system, mental disorders, systemic diseases, immunodeficiency diseases, etc., as determined by the researcher to be unsuitable for follow-up observation; c. Other situations assessed by the researcher as not suitable for inclusion, such as those diagnosed with pelvic floor syndrome, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of spontaneous bowel movements (SBM) after one week of treatment. A spontaneous bowel movement is defined as any bowel movement that occurs more than 24 hours after the use of rescue medica; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the Patient Assessment of Constipation Symptom (PAC-SYM) score of patients with constipation at the 4th week of treatment compared to the baseline score;The fecal consistency scores for the first, second, third and fourth weeks of treatment;The 24-hour SBM response rate in the first treatment session;The number of complete spontaneous bowel movements (CSBM) during the first, second, third and fourth weeks of treatment;First SBM time;The number of SBM occurrences during the second, third and fourth weeks of treatment; | — |
Countries
China
Contacts
Public ContactChen Kequan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed