Chronic constipation with diabetes mellitus or without diabetes mellitus
Conditions
Interventions
Luganos NF jelly is orally administered twice a day for 8 weeks to chronic constipation patients with diabetes.
Luganos NF jelly is orally administered twice a day for 8 weeks to chronic constipatio
Sponsors
Aichi medical University of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have chronic constipation and who need to take constipation medications (including IBS-C) for daily clinical use (2) Patients who have not changed the type of constipation treatment, medication or dosage for 4 weeks before the start of medication, or who have not been treated with constipation treatment (3)Japanese patients who were 20 years or older at the time of giving consent, and who signed informed consent documents. (4)Patients who can make outpatients visit and are not scheduled to be hospitalized "(5)Patients who can keep bowel movement diary and answer questionnaires on their own (6)Patients with stable medical condition who are expected to have no change in medication content, except for the treatment for constipation during the study period
Exclusion criteria
Exclusion criteria: 1:Patients who have been taking lactulose for 4 weeks before the start of medication 2:Patients who have newly taken concomitant medications (anticholinergic or cholinergic drug, opioid, antispasmodic drug, gastrointestinal tract prokinetic drug, GLP-1 receptor agonist, Metformin preparations, a-glucosidase inhibitors) that may affect their bowel habits for 4 weeks before or just before the start of medication. 3:Patients with constipation due to organic disease, patients with large colon or large rectum 4:Patient with pseudo intestinal obstruction 5:Patients who underwent abdominal surgery within one year before the screening test started 6:Patients who have had digestive tract resection (except for polypectomy) 7:Patients with cancer (except cured patients), patients with severe liver disease, severe heart disease 8:Patients who have suffered a stroke within 26 weeks before the screening test starts 9:Patients with galactosemia 10:Patients who participated in other clinical trials within 12 weeks before the screening test starts 11:Patients who donated blood within 12 weeks before the screening test starts 12:Patients who are or may be pregnant, who wish to become pregnant, or who are lactating 13:Patients who were judged by the doctor in charge to be inappropriate for the participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline SBM frequency at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Weekly average of SBM frequency at week 8 (2)Weekly average of SBM frequency at week 0, 4 and change from baseline SBM requency at week 4 (3)Weekly average of the following test items at week 0, 4, 8 and change from baseline at week 4 and 8. Complete SBM frequency, defecation frequency, straning, sensetion of incomplete evacuation, stool consistency score, abdominal distension score, abdominal discomfort (4)Use of rescue medication and cumulative use over 8 weeks (5)The following test items at 0, 4, 8 week-visit and change from baseline at week 4 and 8 Severity of constipation, satisfaction score, QOL score (JPAC-QOL, GSRS)" (6)Glucose, HbA1c, creatinine, BUN, indoxyl sulfate, TMAO, eGFR at week 0, 8 and changes from baseline at week 8 (7)The following test items at 0 and 8 weeks Fecal bacterial flora, short-chain fecal fatty acid, putrefactive products and fecal bile acids" (8)Adverse events, side effects | — |
Countries
Japan
Contacts
Public Contactkazunori adachi
Aichi medical University of medicine gastroenterology
Outcome results
None listed