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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027836
Receipt No. R000031887
Scientific Title The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2017/06/20
Last modified on 2017/11/30

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

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

Objectives
Narrative objectives1 To verify the effects of the test food on defecation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1. Bowel movement diary
2. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Keep it from a week before screening test and a week before consuming to 4 weeks after consuming
*2 Assess at 0 and 4 weeks after consuming
Key secondary outcomes 1. Bacterial flora analysis (T-RFLP)
2. Bristol scale
*1,2 Assess at 0 and 4 weeks after consuming

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 4 weeks
Test materials: Konjac processed food
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
Interventions/Control_2 Duration: 4 weeks
Test materials: Konjac processed food
Dose: 2 packs a day (1 pack for once)
Administration: Take 1 pack in the morning and evening. If you take either breakfast or dinner, take the test food 15 minutes before the meal.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
Interventions/Control_3 Duration: 4 weeks
Test materials: Placebo
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
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 adults

2. Those who defecate three to five times per week

3. Those who are considered as appropriate for the study by the physician

4. Among the people who passed 3., 3 or more male and 3 or more female are selected from each generation (20s, 30s, 40s, 50s, and 60s). (e.g., 6 or more people are selected from each generation.)

5. Among the people who passed 4., those who have relatively few defecation frequency during a week before screening and advance examination

6. Among the people who passed 5., those who have relatively high score in the Japanese version of Constipation Assessment Scale MT version (CAS-MT)
Key exclusion criteria 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines and/or herbal medicines

5. Those who are allergic to medicines, milk, beans, orange, and/or other food products

6. Those who are pregnant, breast-feeding, and plan to become a pregnant

7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

8. Others considered as inappropriate for the study by the physician
Target sample size 30

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

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

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization ORIHIRO Plantdew Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 20 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 Completed
Date of protocol fixation
2017 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031887

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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