Chronic functional constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis consistent with Rome IV criteria for chronic constipation, with the presence of at least two or more of the following seven symptoms: •Sensation of anorectal obstruction or blockage during defecation in =25% of bowel movements; •Straining during defecation in =25% of bowel movements; •Lumpy or hard stools in =25% of bowel movements; •Sensation of incomplete evacuation in =25% of bowel movements; •Manual maneuvers required to facilitate defecation (e.g., digital evacuation or pelvic floor support) in =25% of bowel movements; •Fewer than three spontaneous bowel movements (SBMs) per week; •Rare occurrence of loose stools without the use of laxatives. 2.Age between 18 and 70 years. 3.No prior systematic treatment for constipation.
Exclusion criteria
Exclusion criteria: 1.Severe underlying diseases, including: •Decompensated heart failure (New York Heart Association [NYHA] class III-IV); •Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic pressure >100 mmHg); •Acute coronary syndrome or stroke within the past 6 months. 2.Endocrine or metabolic disorders, including: •Diabetic nephropathy (estimated glomerular filtration rate [eGFR] 3 months) abuse of stimulant laxatives (e.g., senna, bisacodyl). 5.History of special treatments, including: •Gastrointestinal surgery or endoscopic interventions (e.g., intestinal stent placement) within the past 3 months; •Open abdominal surgery (e.g., cholecystectomy, hysterectomy) within the past 6 months; •Presence of abdominal drainage tubes or intestinal stoma. 6.Special physiological conditions: •Pregnancy or lactation (positive blood or urine hCG test). 7.Neuropsychiatric disorders: •Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24); •Neurodegenerative diseases such as Parkinson’s disease or multiple sclerosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete spontaneous bowel movements;Cleveland Clinic Constipation Score;Bristol Stool Scale;Therapeutic Efficacy Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of Quality of Life Scale for Patients with Constipation;Score of Constipation Symptom Inventory; | — |
Countries
China
Contacts
Zhongnan Hospital of Wuhan University