UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Acronym	Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Scientific Title	Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Scientific Title:Acronym	Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effects of the test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation status (fecal properties)
Key secondary outcomes	Defecation status (the number of days of defecation, quantity of defecation, frequency of defecation, color of stool, feeling of residual stool during defecation, abdominal pain during defecation, odor) Intestinal microbiota Intestinal metabolites Blood LPS GSRS (Gastrointestinal Symptom Rating Scale) SF-8 Abdominal symptoms (distention, rumbling, and gas) at times other than defecation

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Ingestion of the test capsules with water for 4 weeks > washout period for 4 weeks > ingestion of the placebo capsules with water for 4 weeks
Interventions/Control_2	Ingestion of the placebo capsules with water for 4 weeks > washout period for 4 weeks > ingestion of the test capsules with water for 4 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. Men and women between the ages of 20 and 64 at the moment of consent 2. Those with loose stool tendency who meet the next two conditions: (1) Who defecate more than 7 times a week; (2) who defecate stools which are categorized as 6 or 7 in the Bristol scale more than once a week 3. Those who have received a full explanation of the study, can understand the contents, and can give a written consent.
Key exclusion criteria	(1) Those who have consumed or will consume oligosaccharide-containing foods for specified health uses or health foods one month before start of test food consumption (2) Those who regularly consume food for specified health use, or health foods that potentially affect the study at least 3 times a week (3) Those who regularly consume foods that potentially affect the test food more than 3 times a week (4) Those who will have taken any medication that will affect the study one month before the pre-test (5) Those who are lactose intolerant (6) Patients with a history of appendectomy (7) Those who underwent surgery that may have affected the study within six months before obtaining consent (8) Heavy alcohol drinkers (9) Those who are planning major changes in their environment during the study period (10) Those with irregular eating habits or irregular lifestyle (11) Those living in the same household who plan to participate in the study (12) Those who are participating in a clinical trial of another drug or health food within 4 weeks after completion of the study, or planning to participate in another clinical trial after participating in the study (13) Patients with a history of heart, liver, kidney, or gastrointestinal diseases (14) Those who are pregnant, lactating, or intending to become pregnant during the study (15) Those who are allergic to drugs/foods (16) Those who have donated 200 mL of blood in one month before start of the study (17) Males who have donated 400 mL of blood within 3 months before start of the study (18) Females who have donated 400 mL of blood within 4 months before start of the study (19) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL (20) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL (21) Those who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Shinnosuke Middle name Last name Murakami
Organization	Metagen, Inc.
Division name	Headquarters
Zip code	997-0052
Address	246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-0052, Japan
TEL	+81-235-64-0330
Email	research@metagen.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	103-0021
Address	4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL	+81-3-6225-9001
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Shionogi Healthcare 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel	+81-3-6225-9005
Email	IRB@cpcc.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	2022 Year 05 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
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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 18 Day
Date of IRB	2022 Year 04 Month 15 Day
Anticipated trial start date	2022 Year 05 Month 18 Day
Last follow-up date	2022 Year 09 Month 21 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 05 Month 16 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054460

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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