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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042267
Receipt No. 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 2020/10/28

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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
Email hori@apt-japan.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo Japan
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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 03-6205-6222
Email suda-clinic_irb@imeq.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
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
2020 Year 09 Month 18 Day
Date of IRB
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
2020 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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