UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects
Acronym	Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects
Scientific Title	Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym	Effects of consumption of the test beverage on the bowel movement and intestinal environment in healthy Japanese subjects
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 beverage for two weeks on the bowel movement and intestinal environment in healthy Japanese subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Defecation frequency in period B*1
Key secondary outcomes	1. Defecation frequency in period A*1 2. Numbers of defecation days and amount of defecation in period B*1 3. Stool shape, stool smell, and exhilarating feeling of defecation in period A and B*1 4. The cumulative number of days with common cold symptoms*2 during the intervention period per subject 5. The diversity index (Chao 1 index, Shannon index), the occupancy rate of bacteria in the stool, immunoglobulin A (IgA) in the stool, and the score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w) 6. Each item of CAS at 2w *1 Period A: 1st week of the start of consumption Period B: 2nd week of the start of consumption *2 The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: Two weeks Test beverage: Lactic fermenting beverage Administration: Drink one bottle (100 ml) per day *If you forget to drink the test beverage, drink it as soon as you remember within the day
Interventions/Control_2	Duration: Two weeks Test beverage: Placebo beverage Administration: Drink one bottle (100 ml) per day *If you forget to drink the test beverage, drink it as soon as you remember within the day
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who defecate three to five times per week 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively few defecation frequency during a week before screening
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who 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. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who take in daily use or cannot stop taking the food containing viable bacteria (such as natto, yogurt, and fermented food), oligosaccharide-fortified food, or lactic fermenting beverage and/or food 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test beverage related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who suffer from COVID-19 10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	30

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 Bldg., 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	Nomura Dairy Products 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	2022 Year 01 Month 25 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	32
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	2022 Year 01 Month 19 Day
Date of IRB	2022 Year 01 Month 19 Day
Anticipated trial start date	2022 Year 01 Month 25 Day
Last follow-up date	2022 Year 04 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 25 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053299