UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046723 |
|---|---|
| Receipt number | R000053299 |
| Scientific Title | Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2022/09/09 08:40:49 |
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Basic information
Public title
Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects
Acronym
Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects
Scientific Title
Effects of consumption of the test beverage on the bowel movement and intestinal environment 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 bowel movement and intestinal environment 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 for two weeks on the bowel movement and intestinal environment in healthy Japanese subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Defecation frequency in period B*1
Key secondary outcomes
1. Defecation frequency in period A*1
2. Numbers of defecation days and amount of defecation in period B*1
3. Stool shape, stool smell, and exhilarating feeling of defecation in period A and B*1
4. The cumulative number of days with common cold symptoms*2 during the intervention period per subject
5. The diversity index (Chao 1 index, Shannon index), the occupancy rate of bacteria in the stool, immunoglobulin A (IgA) in the stool, and the score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w)
6. Each item of CAS at 2w
*1
Period A: 1st week of the start of consumption
Period B: 2nd week of the start of consumption
*2 The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Two weeks
Test beverage: Lactic fermenting beverage
Administration: Drink one bottle (100 ml) per day
*If you forget to drink the test beverage, drink it as soon as you remember within the day
Interventions/Control_2
Duration: Two weeks
Test beverage: Placebo beverage
Administration: Drink one bottle (100 ml) per day
*If you forget to drink the test beverage, drink 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 who defecate three to five times per week
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects who have relatively few defecation frequency during a week before screening
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. 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
4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who take in daily use or cannot stop taking the food containing viable bacteria (such as natto, yogurt, and fermented food), oligosaccharide-fortified food, or lactic fermenting beverage and/or food
6. Subjects who currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medicines and/or the test beverage related products
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who suffer from COVID-19
10. 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
11. 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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Nomura Dairy Products Co., Ltd
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
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 | 01 | Month | 25 | 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
32
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
| 2022 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 16 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053299
