UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030302