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 2021/10/07 10:10:00

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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

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL


Email

n-yuzawa@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

Email

n-yuzawa@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

2021 Year 10 Month 07 Day



Link to view the page

Value
https://center6.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