Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060301) titled 'Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study)' on Jan. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Hyogo Medical University
Condition:
Condition - Chronic constipation diadnosed by Rome IV criteria
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess the effects of magnesium-rich water on bowel movements, constipation symptoms, quality of life (QOL), and safety on chronic constipation.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - soft water
Interventions/Control_2 - magnesium rich water
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key 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.
Key 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
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 25 Day
Date of IRB - 2025 Year 07 Month 03 Day
Anticipated trial start date - 2025 Year 07 Month 07 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066730
Disclaimer: Curated by HT Syndication.
