UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026387
Receipt number R000030302
Scientific Title A verification study on improvements in the immune system and defecation: A randomized open trial
Date of disclosure of the study information 2017/03/03
Last modified on 2021/05/27 11:03:35

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Basic information

Public title

A verification study on improvements in the immune system and defecation: A randomized open 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 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. Scoring of immunological vigor
*Assess at 0 and 4 weeks after consuming

Key secondary outcomes

1. Immunity test
T lymphocyte age, Immunological age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD8+CD28+T cells, T-cell proliferation index, CD4+T cells, CD8+T cells, memory T cells
*Assess at 0 and 4 weeks after consuming

2. Subjective symptoms
a. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
b. Bristol Stool Scale
c. Bowel movement diary
d. The Likert scale method
*Above a, b, and d, assess at 0 and 4 weeks after consuming
*Above c, record when defecating

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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test Material: Nutrient-rich liquid food
Dosage: Drink 1 pack (125 mL) for a day before breakfast

Interventions/Control_2

Duration: 4 weeks
Test Material: Orange juice
Dosage: Drink 1 pack (125 mL) for a day after breakfast

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese adults, who is 65 years and more, are aware of daily fatigue

2. Priority selection is made in the order of II: warning zone, III: observation zone, and IV: safety zone, in immunological grade at baseline
*However, V (sufficiently high) and I (critical zone) are excluded

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. Currently taking supplements

10. Those who are allergic to medicines and/or the test food related products

11. Those who are pregnant, breast-feeding, and plan to become a pregnant

12. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

13. Others considered as inappropriate for the study by the physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

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

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 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

Seishin-kai Medical Association Inc, Takara Medical 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)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 03 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/47010/97

Number of participants that the trial has enrolled

62

Results

Shimono T, Hoshino T, Takara T. Effects of an Oral Nutritional Supplement Drink Containing Lactobacillus paracasei MCC1849 on Improving the Immune System of Elderly People-A Randomized Open-label Trial-. Jpn Pharmacol Ther. 2019; 47(1): 97-113

Results date posted

2021 Year 05 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 01 Month 28 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 02 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 04 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 03 Month 03 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=R000030302


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name