Chronic constipation diadnosed by Rome IV criteria
Conditions
Interventions
soft water
magnesium rich water
Sponsors
Hyogo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be included. 1.Meet the Rome IV diagnostic criteria. 2.In the absence of laxative use, spontaneous soft stools are rare. 3.Do not meet the diagnostic criteria for irritable bowel syndrome.
Exclusion criteria
Exclusion criteria: 1.Persons under 20 years of age or 71 years and older 2.Persons prescribed two or more types of laxatives (including those taking more than 1 g of magnesium oxide) 3.Persons currently drinking commercially available hard water and unable to discontinue its intake for 14 days after consent acquisition 4.Persons with a history of inflammatory bowel disease 5.Persons with a history of gastrointestinal surgery (excluding endoscopic treatments) 6.Persons with renal impairment 7.Persons with cardiac dysfunction 8.Persons diagnosed with hypermagnesemia 9.Persons diagnosed with hypokalemia 10.Persons with a history of aspiration pneumonia 11.Persons with chewing or swallowing difficulties (for those aged 61 or older, a Seirei Swallowing Questionnaire score of 4 or more) 12.Persons with serious systemic diseases such as malignancies or hematologic disorders 13.Pregnant persons or those who may be pregnant 14.Persons suspected of having secondary constipation 15.Persons taking any of the following medications: ??1. Tetracycline antibiotics (e.g., tetracycline) ??2. Fluoroquinolone antibiotics (e.g., ciprofloxacin) ??3. Bisphosphonates (e.g., disodium etidronate) ??4. Cefdinir, cefpodoxime proxetil ??5. Mycophenolic acid, mycophenolate mofetil ??6. Delavirdine, zalcitabine ??7. D-penicillamine ??8. Azithromycin ??9. Celecoxib ??10. Rosuvastatin ??11. Gabapentin ??12. Digitalis preparations (e.g., digoxin) ??13. Iron preparations ??14. Fexofenadine ??15. Polycarbophil calcium ??16. Ion-exchange resins for hyperkalemia treatment (e.g., calcium polystyrene sulfonate) ??17. Active vitamin D3 preparations (e.g., alfacalcidol) ??18. Large amounts of milk or calcium preparations ??19. Misoprostol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall improvement score of constipation symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Bristol stool form 2.Monthly responder rates and weekly change from baseline in spontaneous bowel movement 3.Responder rate of Complete Spontaneous Bowel Movements (CSBMs) 4.Monthly responder rates and weekly change from baseline in complete spontaneous bowel movement 5.Weekly change from baselaine in symptom score of bloating 6.Weekly change from baselaine in symptom score of abdominal discomfort 7,Weekly change from baselaine in symptom score of afeeling of remaining faces 8.Weekly change from baselaine in symptom score of severity of straining 9.he patient assessment of constipation quality of life (JPAC-QOL) and SF-8 10.Change in the Constipation Scoring System (CSS) score 11.Evaluation of stool odor using a Visual Analog Scale (VAS) 12.Frequency of rescue medication use 13.Serum magnesium concentration 14.Serum creatinine concentration | — |
Countries
Japan
Contacts
Public ContactHideki Yoneda
Hyogo Medical University Department of Gastroenterology
Outcome results
None listed