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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028269
Receipt No. 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 2018/07/19

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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
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 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
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 (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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
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
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032351

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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