UMIN-CTR Clinical Trial

Basic information
Public title	Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Acronym	Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Scientific Title	Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Scientific Title:Acronym	Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate the effects on abdominal ache, abdominal discomfort and stool shape due to stress by male and female who continue to taking test food for 4 weeks who aged older 20 years or less than 65 years old.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Izumo scale
Key secondary outcomes	(Secondary outcomes) Defecation survey, special blood test (IL-1beta, IL-6, IL-10, IL-12p70), SF-8 Japanese version, WPAI:GH, intestinal flora test, metabolome analysis (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	4-weeks intake of the test food
Interventions/Control_2	4-weeks intake of the placebo food
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese male and female aged older 20 years or and less than 65 years at the time of the informed consent. 2) Subject who feels stress on a daily basis. 3) Subject who suffering from abdominal ache and diarrhea accompanied by abdominal discomfort. 4) Subject who is judged not to be sick by the doctor's inquiry. 5)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Heavy drinker. 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness (depression) or sleep disturbance. 7)Subject who has irregular work rhythms such as working at night and shift work. 8)Subject who has extremely irregular lifestyle such as eating and sleeping. 9)Subject who has an unbalanced diet. 10)Subject who are currently undergoing treatment for a digestive system disease that affects intestinal function, or who have a history of surgery or history of digestive system disease (Excluding appendectomy). 11)Subject who has or had a history of inflammatory bowel disease, irritable bowel syndrome, or other diseases that are thought to greatly affect bowel movements. 12)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 13)Subject who uses health foods, supplements, and pharmaceuticals that affect bowel function. 14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 15)Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition. 16)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 17)Subject who can't keep the daily records. 18)Subject who is judged as an inappropriate candidate according to the screening data. 19)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takumi Middle name Last name Sato
Organization	Kaneka Corporation
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	530-8288
Address	2-3-18 Nakanoshima Kita-ku Osaka 530-8288, Japan
TEL	050-3133-7669
Email	takumi.sato@kaneka.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Kaneka Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 26 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	60
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 07 Month 07 Day
Date of IRB	2020 Year 07 Month 10 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2020 Year 11 Month 26 Day
Date of closure to data entry	2020 Year 12 Month 25 Day
Date trial data considered complete	2021 Year 01 Month 20 Day
Date analysis concluded	2021 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 20 Day
Last modified on	2021 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047343