UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028269 |
|---|---|
| Receipt number | R000032351 |
| Scientific Title | A verification study on improvements in the immune system and defecation: A randomized open-label trial |
| Date of disclosure of the study information | 2017/07/18 |
| Last modified on | 2021/05/27 11:03:06 |
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Basic information
Public title
A verification study on improvements in the immune system and defecation: A randomized open-label trial
Acronym
A verification study on improvements in the immune system and defecation
Scientific Title
A verification study on improvements in the immune system and defecation: A randomized open-label trial
Scientific Title:Acronym
A verification study on improvements in the immune system and defecation
Region
| Japan |
Condition
Condition
Japanese adults who are healthy or regularly see a doctor
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on immune system and defecation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*Assess at 0 and 4 weeks after consuming
Key secondary outcomes
1. Subjective symptoms
a. Bristol Stool Scale
b. Bowel movement diary
c. The Likert scale method
* Above a and c, assess at 0 and 4 weeks after consuming
* Above b, record when defecating
2. Immunity test
T lymphocyte age, Immunological age, number of T cells, number of CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, NK cells, and CD8+CD28+T cells, T-cell proliferation index, number of CD4+T cells, CD8+T cells and memory T cells
*Assess at 0 and 4 weeks after consuming
3. Saliva test
Salivary immunoglobulin A (sIgA)
*Assess at 0 and 4 weeks after consuming
4. Blood test
High-sensitive CRP, albumin, prealbumin
*Assess at 0 and 4 weeks after consuming
5. Physical examination
Muscle mass, grip strength
*Assess at 0 and 4 weeks after consuming
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Test Material: Probiotic food (high dose)
Dosage: Take 1 pack, three times a day after each meal
Interventions/Control_2
Duration: 4 weeks
Test Material: Probiotic food (low dose)
Dosage: Take 1 pack, once a day after breakfast
Interventions/Control_3
Duration: 4 weeks
Test Material: None
Dosage: None
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Sixty-five years and more Japanese adults who have 2-5 times of defecation per week
2. Those who are considered as appropriate for the study by the physician
3. Above 2, priority selective those who have high CAS scores in CAS-MT at screening and pre-ingestion
Key exclusion criteria
1. Those who have the medical history or under the treatment of malignant tumor
2. Those who have the medical history or under the treatment of autoimmune disease
3. Those who have the medical history or under the treatment of inflammatory bowel disease
4. Those who are currently hospitalized
5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
6. Those who eat Natto, yogurt, and food and beverage including lactic acid bacteria in daily
7. Those who are smokers
8. Those who take anti-allergic drugs
9. Those who take laxative tablets
10. Those who are currently taking supplements
11. Those who are allergic to medicines and/or the test food related products
12. Those who are pregnant, breast-feeding, and plan to become a pregnant
13. Those who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
14. Others considered as inappropriate for the study by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
CLINICO CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/48070/1167
Number of participants that the trial has enrolled
93
Results
Shimono T, Hoshino T, Takahashi Y, Takara T. Synbiotics Containing Bifidobacterium longum BB536 improve bowel movements and enhance immunity in elderly people-A randomized, open-label, parallel-group study-. Jpn Pharmacol Ther. 2020; 48(7): 1167-1177
Results date posted
| 2021 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 30 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 18 | 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
| 2017 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032351
