UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Acronym	Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Scientific Title	Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Scientific Title:Acronym	Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain in Japanese men and women aged 20 to 65.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation questionnaire
Key secondary outcomes	Izumo scale, POMS2 abbreviations, blood cytokines (IL-10, IL-6, TNF-a), faecal mucins, and faecal IgAs

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	Test foods (tablet 250 mg) consumed 1 tablet per day for 8 weeks.
Interventions/Control_2	Placebo foods (tablet 250 mg) consumed 1 tablet per day for 8 weeks.
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 males and females aged 20 to 65 years at the time of informed consent. 2)Persons who are routinely stressed and suffer from diarrhea with abdominal pain and discomfort. 3)Persons who can continuously consume the test food for 8 weeks during the test period. 4)Persons who can visit the medical institution during the study period. 5)Persons who are judged not to be a sick person by an inquiry from a physician. 6)Persons who have received sufficient explanation on the purpose and content of the research, who have the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who have given written consent to participate in the research.
Key exclusion criteria	1)Persons who are currently receiving any drug treatment or ambulatory treatment. 2)Persons who are currently exercising or taking diet under the supervision of a physician. 3)Persons who can't restrict drugs that may affect bowel movements, health foods containing lactobacilli and bifidobacteria, foods for specified health uses, Foods with Function Claims, health supplements, supplements, etc., and foods rich in lactobacilli from the time of acquisition of consent. 4)Patients with gastrointestinal diseases that have an effect on intestinal regulation and who are currently being treated at a medical institution or who have had gastrointestinal surgery (excluding appendectomy). 5)Persons with a history of a disease that is thought to have a major impact on bowel movements. 6)Patients with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 7)Having a history of drug or food allergy. 8)Pregnant or breastfeeder. Those who desire pregnancy and lactation. 9)Persons who can't maintain their usual alcohol intake during the study period. 10)Persons who have donated blood or vaccinated within the past 3 months or scheduled them during the study. 11)Persons with psychiatric disorders or sleep disorders who have a history of psychiatric illness in the past. 12)Alcohol-dependent, drug-dependent, or drug-abused persons who have a history of such treatment. 13)Night workers and shift workers. 14)Persons with irregular habits such as meals and sleep. 15)Persons who have participated in other clinical trials within the past 3 months. 16)Persons who are difficult to record in various questionnaires. 17)Persons who are judged inappropriate for the study by the investigator.
Target sample size	70

Research contact person
Last name of lead principal investigator	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	81-3-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
1st 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	81-3-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	NISSIN FOODS HOLDINGS CO., LTD.
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. 1-27-12 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	2018 Year 10 Month 19 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	70
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	2018 Year 09 Month 14 Day
Date of IRB	2018 Year 08 Month 13 Day
Anticipated trial start date	2018 Year 10 Month 09 Day
Last follow-up date	2018 Year 12 Month 20 Day
Date of closure to data entry	2019 Year 01 Month 30 Day
Date trial data considered complete	2019 Year 02 Month 08 Day
Date analysis concluded	2019 Year 04 Month 25 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039292