Diabetic constipation
Conditions
Interventions
experimental group:Rupiprostenone capsules, 24µg/capsule, 1 capsule/dose, 2 times a day, taken orally with food and water with breakfast and dinner, swallowed whole, not to be split or chewed, for 8 w
Control group 1:Linaclotide, 290 µg/capsule, 1 capsule/dose, 1 day, half an hour before breakfast, swallowed whole, not to be split or chewed, for 8 weeks.
Control group 2:Bifidobacterium bifidum Live Bacteria Capsules, 210mg/capsule, 2 capsules/dose, 2 times a day, after breakfast and dinner, swallowed whole, not to be split or chewed, for 8 weeks.
Sponsors
Binzhou Medical University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntary signed informed consent was obtained from the subjects prior to the start of the study (2) Age 18-75 years old, gender is not limited (3) Meet the diagnostic criteria for diabetes mellitus: adopt the diagnostic criteria for diabetes mellitus issued by the American Diabetes Association in 2010, i.e., satisfy one of the conditions 1-4: ?glycated haemoglobin HbAlc >6.5%. ?fasting blood glucose FPG =7.0 mmol/L. Fasting is defined as having no calorie intake for at least 8 h. ?2-h blood glucose =11.1 mmol/L in the oral glucose tolerance test. Oral glucose tolerance test using 75g of anhydrous dextrose according to WHO standards).?Random blood glucose =11.1mmol/L in patients with typical hyperglycaemia or symptoms of crisis. ?Repeat the test when there is no clear hyperglycaemia to confirm the criteria ?-? (4) Meets diagnostic criteria for constipation: an average of <3 spontaneous bowel movements per week and =1 of the following symptoms in at least 25% of the bowel movements: very hard (pellets) and/or hard stools, sensation of incomplete emptying and/or straining to defecate (5) Patients with a colonic transport test showing the presence of a slow transport (6) Those who are able to follow a strict pre-test diet and are able to take medication as required by the protocol (7) Those who are able to complete the subject log card and study questionnaire as required by the trial protocol
Exclusion criteria
Exclusion criteria: (1) Those with a previous history of rupiprostenone medication (2) Chronic constipation due to medications, such as antidepressants, opioids, and antiepileptic drugs (3) Those who are allergic to rupiprostenone and control drugs or corkscrew (containing glycerin) (4) Those with symptoms of irritable bowel syndrome (IBS) (5) Have a history of malignancy (6) History of abdominal surgery within six months (except appendectomy, cholecystectomy, and planned delivery) (7) Those with other organic lesions of the gastrointestinal tract or other serious diseases of the heart and lungs (8) Women with a positive pregnancy test or with a plan to become pregnant and women who are breastfeeding (9) Those who have used anticholinergic drugs, antispasmodics, pro-secretory laxatives, other gastrointestinal pro-dynamic drugs, traditional Chinese medicines, proprietary Chinese medicines, intestinal laxatives and weight loss teas, and antibiotics such as erythromycin, roxithromycin, and other antibiotics that affect gastrointestinal function and probiotics in the 30 days prior to the start of the trial (10) Those with severe complications of diabetes mellitus combined (11) Those who have participated in other clinical medical studies within the past 3 months (12) Those with poor glycaemic control within the past 3 months (13) Those with clinically significant laboratory test abnormalities that, in the judgement of the investigator, make participation in the study inappropriate (14) Those who are unable to comply with the trial protocol (15) Constipation types such as outlet obstruction constipation, mixed constipation, anal fissure constipation and congenital megacolon constipation (16)Any other condition that the investigator considers unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of spontaneous bowel movements (SBM) before and after treatment;Effective results of colonic transport experiments before and after treatment;Time of balloon forcing out experiment before and after treatment;Anorectal manometry results before and after treatment;Results of 16srDNA sequencing of the genome of E. faecium;Trace Factor Detection;Effective defecation time;Bristol faecal pattern;Anxiety Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| PAC-SYM, PAC-SYM Rating Scale;Analysis of symptoms such as abdominal pain and feeling of incomplete bowel movement;Analysis of changes in blood glucose and other adverse reactions; | — |
Countries
China
Contacts
Public ContactChen Yan
Binzhou Medical University Hospital
Outcome results
None listed