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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024673
Receipt No. R000028383
Scientific Title A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans
Date of disclosure of the study information 2016/11/01
Last modified on 2017/12/28

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Basic information
Public title A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans
Acronym A trial for improving the intestinal environment in humans
Scientific Title A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans
Scientific Title:Acronym A trial for improving the intestinal environment in humans
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 to ingest 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. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, and Clostridium subcluster XIVa)
*1 Perform the test at 0 week and at 1 and 2 weeks after ingestion
Key secondary outcomes 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion

2. Stool form scale
*2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion

3. Bowel movement diary
*3 Record it when having bowel movements

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: 2 weeks
Test material: White Lactic acid bacterium Onakani Yell
Dose: A bottle (65 mL) of per day
Administration: Drink it after breakfast, lunch or dinner.
Interventions/Control_2 Duration: 2 weeks
Test material: Placebo
Dose: A bottle (65 mL) of per day
Administration: Drink it after breakfast, lunch or 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 or have medical history 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 Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage and/or food

4. Subjects who currently take medicines (include herbal medicines) and/or supplements

5. Subjects who are allergic to medicines or relate to the test food of this trial

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

7. Subjects who have enrolled into other clinical trials within the last 3 months before the date signed written informed consent in this trial

8. Subjects are judged as unsuitable for participating in this trial by physician for other reasons
Target sample size 40

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 White Food Industry 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 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Iwasaki S, Yokoi K, Suzuki N, Yamashita S, Iio S, Takara T. Effects of a Drink Containing Lactobacillus casei on Improving the Intestinal Environment in People with Constipation-A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2017; 45(12): 1947-1962.
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 10 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 02 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 11 Month 01 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028383

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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