Chronic functional constipation
Conditions
Interventions
(Part 1 of the study) Control group:Polyethylene glycol 4000 10gbid for 4 weeks
(Part 1 Research) Research Group:Lubisprostone 24µg bid for 4 weeks
(Part 2 of the study) Control group:standard bowel preparation and colonoscopy, if 1 week later constipation persists, continue to use polyethylene glycol 4000 powder 10gbid for 4 weeks
(Part 2 Research) Research Group 1:Lubisprostone 24µg bid X2days+standard bowel preparation and colonoscopy, if 1 week later constipation persists, coLubisprostone 24µg bid for 4 weeks
(Part 2 Research) Research Group 2:Lubisprostone 24µg bid X7days+standard bowel preparation and colonoscopy, if 1 week later constipation persists, coLubisprostone 24µg bid for 4 weeks
Sponsors
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age range from 18 to 75 years old; 2) Complies with the diagnostic criteria for chronic functional constipation in the Chinese Chronic Constipation Diagnosis and Treatment Guidelines (2013, Wuhan)
Exclusion criteria
Exclusion criteria: 1) Constipation caused by organic intestinal diseases such as intestinal tumors, intestinal stenosis or obstruction, megacolon, intestinal torsion, rectal prolapse, etc; 2) Constipation caused by endocrine and metabolic diseases such as severe dehydration, uncontrollable diabetes, uncontrollable thyroid and parathyroid dysfunction, multiple endocrine adenoma, heavy metal poisoning, hypercalcemia, high or low magnesium, hypokalemia, porphyria, chronic kidney disease, uremia, etc; 3) Constipation caused by neurological diseases such as autonomic neuropathy, cerebrovascular disease, cognitive impairment or dementia, multiple sclerosis, Parkinson's disease, spinal cord injury, etc; 4) Constipation caused by muscle diseases such as amyloidosis, dermatomyositis, scleroderma, systemic sclerosis, etc; 5) Constipation caused by drugs such as antidepressants, antiepileptics, antihistamines, antipsychotic drugs, antispasmodic drugs, calcium antagonists, diuretics, monoamine oxidase inhibitors, opioids, sympathetic nervous system drugs, aluminum or calcium containing antacids, calcium, iron, antidiarrheals, non steroidal anti-inflammatory drugs, etc; 6) Pregnancy; 7) Allergies to Lubiprostone, polyethylene glycol, and silicone oil; 8) Take antibiotics, acid suppressants, bismuth supplements, probiotics, etc. within the past 3 months; 9) Inability to tolerate colonoscopy, coagulation, platelet abnormalities unsuitable for biopsy, and other situations deemed unsuitable for inclusion in the study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of Lubisprostone on gut microbiota in patients with chronic functional constipation after treatment and colonoscopy examination;The effect of Lubisprostone on intestinal barrier function after colonoscopy in patients with chronic functional constipation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of Lubisprostone on symptoms and quality of life in patients with constipation;The effect of Lubisprostone combined with polyethylene glycol on intestinal preparation in patients with chronic functional constipation; | — |
Countries
China
Contacts
Public ContactXue Yang
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Outcome results
None listed