UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047765
Receipt No. R000054456
Scientific Title Effects of consumption of the test beverage on the defecation in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2022/05/16
Last modified on 2022/06/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
Acronym Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
Scientific Title Effects of consumption of the test beverage on the defecation in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym Effects of consumption of the test beverage on the defecation in healthy Japanese subjects
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 effects of consumption of the test beverage on the bowel movement in healthy Japanese subjects whose defecation frequency is three to five times per week
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Defecation frequency at the 2nd week after consumption of test beverage
Key secondary outcomes 1. Defecation frequency at the 1st week after consumption of test beverage

2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of test beverage

3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of test beverage

4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w)

5. Each item of CAS at 2w

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 Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: Two weeks
Test beverage: Beverage containing lactic acid bacteria and yeast
Administration: Drink one pack each before breakfast and dinner (two packs per day)

*Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.
Interventions/Control_2 Duration: Two weeks
Test beverage: Placebo beverage
Administration: Drink one pack each before breakfast and dinner (two packs per day)

*Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.
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. Japanese

2. Men or women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects whose defecation frequency is three to five times per week

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

7. Subjects whose defecation frequency is relatively few during a week before the screening (before consumption)
Key exclusion criteria 1. Subjects who have drinkning habit on an empty stomach or who sometimes have diarrheal due to drinking

2. Subjects who are diarrheal tendency

3. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

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

5. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

6. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use

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

8. Subjects who are allergic to medicines and/or the test beverage related products

9. Subjects who are pregnant, lactation, or planning to become pregnant

10. Subjects who suffer from COVID-19

11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

12. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

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 maikon no kohara Corporation.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi 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 IRB@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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2022 Year 05 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 34
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 No longer recruiting
Date of protocol fixation
2022 Year 04 Month 20 Day
Date of IRB
2022 Year 04 Month 20 Day
Anticipated trial start date
2022 Year 04 Month 28 Day
Last follow-up date
2022 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 16 Day
Last modified on
2022 Year 06 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.