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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038362
Receipt No. R000043720
Scientific Title The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2020/04/01
Last modified on 2020/05/07

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Basic information
Public title The verification study for improving the intestinal environment
Acronym The verification study for improving the intestinal environment
Scientific Title The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym The verification study for improving the intestinal environment
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the improving effects on the intestinal environment of intaking the test food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Defecation frequency per week
Key secondary outcomes 1. Numbers of defecation days per week
2. Amount of defecation per week
3. Shape of stool
4. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
5. Bristol Stool Scale
6. Occupancy rate of enteric bacteria
7. Actual bacterial count of Bifidobacterium
8. Fecal pH
9. Water content in feces
10. Organic acids in feces
11. Putrefactive products in feces
12. Bile acids in feces
13. Facial skin assessment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 2 weeks
Test food: Fermentation product of soy milk with lactic acid bacteria
Interventions/Control_2 Duration: 2 weeks
Test food: Lactic acid bacteria-free sour clotted soy milk made of soy milk and lactic acid
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects

2. Subjects who defecate three to five times per week

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects whose actual bacterial count of Bifidobacterium is not 0

5. Subjects who have relatively few defecation frequencies in a week before screening (before consumption)
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS), or any other chronic diseases

4. Subjects who daily take "Foods for Specified Health Uses", "Foods with Functional Claims", yogurt, lactic fermenting beverage, or other functional food/beverage. Particularly taking food/beverage effective in intestine regulating.

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization KIKKOMAN SOYFOODS COMPANY
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 01 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 44
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
2019 Year 10 Month 07 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2019 Year 10 Month 23 Day
Last follow-up date
2019 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 23 Day
Last modified on
2020 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043720

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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