Constipation
Conditions
Interventions
Experimental group:Patients who meet the inclusion criteria will receive 12weeks of lubiprostone treatment, 1 pill per dose,BiD
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: a. Aged 65 or over, with no gender restrictions; b. Meeting the Rome IV diagnostic criteria for functional gastrointestinal disorders; c. Patients have undergone a total colonoscopy within the 2 years prior to the screening period or during the screening period, and the results were clear; d. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: a. Suspected or diagnosed with organic abnormalities in the intestines (obstruction, stenosis, cancer), inflammatory bowel disease, megarectum/megacolon, or pseudo-obstruction; b. Patients with a history of digestive tract or gynecological surgery within the past 3 months; c. Patients with severe cardiovascular system diseases, as judged by the researcher to be unsuitable for participating in the study; d. Abnormal laboratory tests with clinical significance, as judged by the researcher to be unsuitable for participating in the study, including: I. ALT and/or AST > 2 times the upper limit of normal (ULN) II. TBIL >=1.5 times the upper limit value III. Cr higher than the upper limit of normal value; e. Patients with a history of hyperthyroidism or hypothyroidism; f. Other conditions deemed unsuitable for enrollment by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of Stool Bowel Movements (SBM) during the 1th week of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| frequencies of SBM;Spontaneous defecation response rate;The time of the first spontaneous defecation;Complete spontaneous defecation frequency;Complete spontaneous defecation response rate;Fecal trait score;Quality of Life Scale for Constipation Patients;Constipation Symptom Self Rating Scale; | — |
Countries
China
Contacts
Public ContactLiu Yulan
Peking University People's Hospital
Outcome results
None listed