UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054620 |
|---|---|
| Receipt number | R000062412 |
| Scientific Title | Effects of consumption of the test food on bowel movement in healthy Japanese who tend to have loose stools: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2024/08/21 15:26:28 |
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Basic information
Public title
Effects of consumption of the test food on bowel movement in healthy Japanese who tend to have loose stools
Acronym
Effects of consumption of the test food on bowel movement in healthy Japanese who tend to have loose stools
Scientific Title
Effects of consumption of the test food on bowel movement in healthy Japanese who tend to have loose stools: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on bowel movement in healthy Japanese who tend to have loose stools
Region
| Japan |
Condition
Condition
Healthy Japanese
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 food on bowel movement in healthy Japanese who tend to have loose stools.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of defecation frequency in period 9*
*Period 9: Seven days from the 50th day of intervention
Key secondary outcomes
1. The measured value of defecation frequency in period 2~8*
2. The measured values of number of days with defecation and amount of defecation in period 2~9*
3. The individuals whose stool shape, stool color, stool smell, and exhilarating feeling of defecation improved by at least one level in period 2~9 compared to period 1*
4. The individuals whose defecation frequency in period 9 is five times or more and nine times or less
5. The rate of defecation frequency which stool shapes are classified as "slightly loose stool," "muddy stool," or "watery stool" in period 9 and the individuals have less than 50% of the above defecation
<Definition>
(The number of "slightly loose stool," "muddy stool," or "watery stool" in period 9 / the defecation frequency in period 9) <0.5
6. The individuals whose defecation frequency in period 9 is five times or more and nine times or less and whose defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 9
7. The total score and each subscale of the Izumo Scale (Reflux, Pain, Fullness, Constipation, Diarrhea) at eight weeks after intervention (8w)
8. Shannon's diversity index, Observed operational taxonomic units (OTUs), Faith's Phylogenetic Diversity, and the abundance ratio of gut microbiota (Level 6: genus level) at 8w
* Period 1: Seven days prior to screening (before intervention; Scr)
Period 2: Seven days from the start of intervention
Period 3: Seven days from the 8th day of intervention
Period 4: Seven days from the 15th day of intervention
Period 5: Seven days from the 22nd day of intervention
Period 6: Seven days from the 29th day of intervention
Period 7: Seven days from the 36th day of intervention
Period 8: Seven days from the 43rd day of intervention
Period 9: Seven days from the 50th day of intervention
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: Beverage containing lactic acid bacteria
Administration: Take one bottle per day (100 mL)
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: Eight weeks
Test food: Beverage not containing lactic acid bacteria
Administration: Take one bottle per day (100 mL)
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose defecation frequency for seven days prior to Scr is 10 times or more and 20 times or less
6. Individuals whose defecation frequency which stool shape are classified as "slightly loose stool (5)" or "muddy stool (6)" in the Bristol stool scale are 50% or more of the total defecation frequency for seven days prior to Scr
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator
3. Individuals who are undergoing treatment for any of cardiac arrhythmia, hepatopathy, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases
4. Individuals who take "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)"
5. Individuals who take or use medicines (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product, especially bananas, peaches, Japanese pears, grapes, or other fruits
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who suffer from diarrheal disease
9. Individuals who have had diarrhea for at least 2 weeks before agreeing to participate
10. Individuals who meet the diagnostic criteria for irritable bowel syndrome (IBS) or have already been diagnosed with IBS
11. Individuals who drink alcohol >20 g/day
12. Individuals who have other diseases that may substantially affect bowel movement
13. Individuals who usually take foods rich in lactic acid bacteria (LAB), or health foods (e.g. yogurt, drink, supplements) or medicines fortified with LAB
14. Individuals who usually take medicines, health foods, FOSHU, or FFC that may affect bowel movement/take foods fortified with ingredients affecting bowel movement (e.g. fermented foods such as natto, kimchi, or pickles, foods fortified with dietary fiber)
15. Individuals who cannot keep the test food refrigerated
16. Individuals who have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during this study
17. Individuals who are judged as ineligible to participate by the physician
Target sample size
60
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 Bldg., 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
| 2024 | Year | 06 | Month | 30 | 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
68
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
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062412
