UMIN-CTR Clinical Trial

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