UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on bowel movement
Acronym	Effects of consumption of the test food on bowel movement
Scientific Title	Effects of consumption of the test food on bowel movement: A randomized double-blind placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of the test food on bowel movement
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on bowel movement in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured value of defecation frequency at period VI
Key secondary outcomes	1. The amounts of changes from periods I or II of defecation frequency in period VI 2. The measured values and amounts of changes from periods I or II of defecation frequency in periods III to V 3. The measured values and amounts of changes from periods I or II of defecation days and amount of defecation in periods III to V 4. The measured values of shape and smell of stool and exhilarating feeling in periods III to VI 5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at two and four weeks after consumption (2w, 4w) 6. The measured values of scores for each item of CAS-MT at 2w and 4w 7. The measured values and amounts of changes from Scr of the following items at 4w: total number of bacteria, numbers of lactic acid bacteria, Bifidobacterium, and Clostridium perfringens, salivary immunoglobulin A (s-IgA), scoring of immunological vigor, T lymphocyte age (upper limit), the numbers of T cells, naive T cells, B cells, NK cells, and CD8+CD28+T cells and the ratios of CD4+T cells to CD8+T cells and naive T cells to memory T cells 8. The measured values of the following items at 4w: immunological grade, the scores of T cells, CD8+CD28+T cell ratios, ratio of CD4+T cells to CD8+T cells, naive T cells, ratio of naive T cells to memory T cells, B cells, and NK cells 9. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*) during the intervention period per group 10. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*), and the maximum duration of the days with common cold symptoms (*) during the intervention period per subject #: Feverishness, nasal discharge, blocked nose, throat pain, cough, sneezing, whole body malaise, muscle pain, joint pain, chilliness, fatigue, physical condition, and headache *: The common cold symptom is defined as the onset of any one of #.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: Four weeks Test food: Tablets containing high levels of lactic acid bacteria Administration: Take one tablet per day with water after dinner within 30 minutes * Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Interventions/Control_2	Duration: Four weeks Test food: Tablets containing moderate levels of lactic acid bacteria Administration: Take one tablet per day with water after dinner within 30 minutes * Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Interventions/Control_3	Duration: Four weeks Test food: Tablets containing low levels of lactic acid bacteria Administration: Take one tablet per day with water after dinner within 30 minutes * Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Interventions/Control_4	Duration: Four weeks Test food: Tablets without lactic acid bacteria Administration: Take one tablet per day with water after dinner within 30 minutes * Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who defecate three to five times per week 6. Subjects who are aware that they easily feel fatigue and get sick. 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who have relatively few defecation frequency during a week before Scr
Key exclusion criteria	Subjects (who) 1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.take "Foods for Specified Health Uses", "Foods with Functional Claims", foods containing viable fungi such as natto, yogurt, and fermented foods, foods fortified with oligosaccharides and dietary fiber, foods containing high amounts of sugar alcohol, food/beverage containing lactic acid bacteria, or other functional food/beverage in daily use and unable to quit the intake during the test period 5.regularly use medicines related to bowel movement, such as intestinal regulator and laxatives 6.currently taking medicines (include herbal medicines) and supplements 7.affected from pollen allergy 8.have received vaccination for infectious diseases such as influenza within a year 9.are smokers, or started smoking cessation within a year 10.drink an excess of alcohol *weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)] 11.are planning to go abroad or have a job transfer during this trial 12.are allergic to medicines and/or the test food related products. Particularly, lactic acid bacteria, vitamin D, starch, sucrose fatty acid ester, or hydroxypropylmethylcellulose capsule 13.are lactating, pregnant, or intending to become pregnant 14.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial 15.are judged by the principal investigator as ineligible to participate in the trial
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Suzuki
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Fujicco Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 12 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	88
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	2020 Year 12 Month 11 Day
Date of IRB	2020 Year 12 Month 11 Day
Anticipated trial start date	2020 Year 12 Month 18 Day
Last follow-up date	2021 Year 04 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2021 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048835