UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060301 |
|---|---|
| Receipt number | R000066730 |
| Scientific Title | Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study) |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 15:35:50 |
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Basic information
Public title
Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study)
Acronym
Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study)
Scientific Title
Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study)
Scientific Title:Acronym
Randomized study of Effects of magnesium-rich water on LAxation in patients with eXperienced constipation (RELAX study)
Region
| Japan |
Condition
Condition
Chronic constipation diadnosed by Rome IV criteria
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall improvement score of constipation symptoms.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
soft water
Interventions/Control_2
magnesium rich water
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Shinzaki |
Organization
Hyogo Medical University
Division name
Department of Gastroenterology
Zip code
663-8501
Address
1-1, Mukogawa-chou, Nishinomiya, Hyogo
TEL
0798456111
hi-yoneda@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Yoneda |
Organization
Hyogo Medical University
Division name
Department of Gastroenterology
Zip code
663-8501
Address
1-1, Mukogawa-chou, Nishinomiya, Hyogo
TEL
0798456661
Homepage URL
hi-yoneda@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa-chou, Nishinomiya, Hyogo
Tel
0798456111
hi-yoneda@hyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066730
