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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023156
Receipt No. R000026691
Scientific Title A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
Date of disclosure of the study information 2016/07/14
Last modified on 2017/01/30

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

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

Objectives
Narrative objectives1 To verify the improvement of intestinal environment due to ingestion of the test food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Total intestinal bacterial count
*1 Perform the test at 0 week and at 2 and 4 weeks after the ingestion
Key secondary outcomes 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Answer CAS-MT at 0 week and at 2 and 4 weeks after the ingestion

2. Stool form scale
*2 Answer stool form scale at 0 week and at 2 and 4 weeks after the ingestion

3. Bowel movement diary
*3 Recording about the defecation every day

4. Analysis of peripheral blood {Diacron-Reactive Oxygen Metabolites (d-ROM), Bone Specific Alkaline Phosphatase (BAP)}
*4 Perform the test at 0 week and 4 weeks after the ingestion

5. Stool analysis {Stool IgA, organic acids (succinic acid, lactic acid, formic acid, acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid), ammonia}
*5 Analyze at 0 week and at 2 and 4 weeks after the ingestion (Stool IgA: Analyze at 0 week and 4 weeks after the ingestion)

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 Duration: 4 weeks
Test material: ALBEX
Dose: Drink 10 mL twice a day
Administration: To drink ALBEX with a cup of water before breakfast and dinner
Interventions/Control_2 Duration: 4 weeks
Test material: Placebo
Dose: Drink 10 mL twice a day
Administration: To drink Placebo with a cup of water before breakfast and dinner
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 adults

2. Persons who defecate two to five times per week
Key exclusion criteria 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who being treated for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Subjects who currently take medicines (include herbal medicines)

4. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or bifidobacteria and lactic acid bacteria beverage, bifidobacteria and lactic acid bacteria contains food

5. Subjects who are allergic to medicines or foods related to the test materials of this trial, particularly allergic to soy

6. Subjects who currently take supplements or nutrition enrichments

7. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period

8. Subjects who have enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

9. Subjects are decided as unsuitable for participating in this trial by physician for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
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
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 B&S corporation Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
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
Seishin-kai Medical Association Inc, Takara Medical Clinic.

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 14 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
2016 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 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
2016 Year 07 Month 13 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026691

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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