UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042267 |
|---|---|
| Receipt number | R000048202 |
| Scientific Title | Examination of the effect of electrolytic nano-platinum water intake on intestinal bacterial flora. |
| Date of disclosure of the study information | 2020/11/16 |
| Last modified on | 2024/05/17 14:31:22 |
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Basic information
Public title
Examination of the effect of electrolytic nano-platinum water intake on intestinal bacterial flora.
Acronym
Examination of the effect of electrolytic nano-platinum water intake on intestinal bacterial flora.
Scientific Title
Examination of the effect of electrolytic nano-platinum water intake on intestinal bacterial flora.
Scientific Title:Acronym
Examination of the effect of electrolytic nano-platinum water intake on intestinal bacterial flora.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of electrolytic nano-platinum water intake for 8 weeks on constipation-prone subjects aged between 20 and 65 years old and having 2 to 5 bowel movements per week.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation survey (number of defecations, fecal properties by Bristol score, defecation volume, abdominal symptoms), stool short-chain fatty acid analysis, intestinal flora
Key secondary outcomes
Immune system markers (CD4, CD8), saliva sIgA measurement, endotoxin, serotonin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Drink 1000 ml (500 ml x 2 bottles) of electrolytic nano-platinum water daily. (Cannot be heated or used for cooking.)
Interventions/Control_2
Drink 1000 ml (500 ml x 2 bottles) of placebo water daily. (Cannot be heated or used for cooking.)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 65 at the time of informed consent.
2. Men and Women
3. Those who defecate 2 to 5 times a week
4. Those who can drink 500 ml of water x 2 bottles a day
5. Those who can input electronic diary with smartphone / PC
6. Those who can obtain written consent
Key exclusion criteria
1. Those who drink electrolyzed water (water generated by the generator) or hydrogen water on a daily basis
2. Currently being treated with drugs (abortive use is acceptable
, but antibiotics and gastric acid secretion inhibitors cannot be used)
3. Those who have received antibiotics within the last 2 months
4. Those who have a current or history of serious illness
5. Those who have undergone surgical intestinal resection in the past
6. Those who take medicines, health foods, supplements, foods for specified health use, foods with functional claims that affect the intestinal function on a daily basis
7. Those who take yogurt and lactic acid bacteria drinks daily
8. Those who have a current or history of food allergies or drug allergies
9. Those who have excessive drinking habits
10. Those who have a smoking habit
11. Those who are currently pregnant or breastfeeding, or who wish to become pregnant during the test period
12. Those who are judged to be unsuitable for participation in this study by the investigators or the sub-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Hori |
Organization
Mr. Waterman Co., Ltd.
Division name
CEO
Zip code
194-0041
Address
8-7-7 Tamagawagakuen Machida city Tokyo
TEL
042-721-9130
hori@apt-japan.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
trim Ltd.
Mr. Waterman Co., Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2020 | Year | 11 | Month | 16 | 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
20
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048202
