UMIN-CTR Clinical Trial

Basic information
Public title	Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study
Acronym	Effects of probiotics on intestinal environment in healthy adults
Scientific Title	Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study
Scientific Title:Acronym	Effects of probiotics on intestinal environment in healthy adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the effect on intestinal environment by intervation with enteric seamless capsule containing probiotics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency
Key secondary outcomes	* Analysis of intestinal microbiota * Stool volume, shape, color, smell and feeling after defecation * Constipation assessment scale

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Take one pack of test-food-1 a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-2 a day for 2 weeks - Washout 4 weeks - Take one pack of control-food a day for 2 weeks
Interventions/Control_2	Take one pack of test-food-2 a day for 2 weeks - Washout 4 weeks - Take one pack of control-food a day for 2 weeks - Washout 4 weeks - Take one pack of test-food -1 a day for 2 weeks
Interventions/Control_3	Take one pack of control food a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-1 a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-2 a day for 2 weeks
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 20 to 60years old. (A half of subjects aim to be men, and the generation of subjects aim to be dispersed.) 2) Subjects who defecate 3 to 5 times in a week. 3) Subjects who show low occupancy of Bifidobacterium in their feces. 4) Subjects who do not routinely consumed fermented foods, health foods which contain dietary fiber, and supplements, during the examination period. 5) Subjects who are explained about the study, show understanding of the study procedures, and show agreement with participating to the study by written informed consent prior to the study.
Key exclusion criteria	1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start. 2)Subjects who didn't take antibiotics within 6 month before test start. 3) Subjects who have allergy to test food. 4)Smokers 5)Subjects who are heavy drinkers of alcohol. 6) Subjects whose living together (consort or partner etc.) has plan to participate to the same clinical test. 7) Subjects who plan big change of lifestyle during test period. 8)Subjects with tendency of chronic diarrhea. 9)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 10)Subjects who suspected chronic or serious infectious disease. 11) Females who are pregnant (including the possibility of pregnancy) or are lactating. 12) Subjects who have participated to the other clinical test within 1 month before test start. 13) Subjects who have consumed medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment since 2 weeks before the day of advance examination. 14) Subject who cannot refrain from consumption of medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment during test period. 15) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Kodama
Organization	MORISHITA JINTAN CO.,LTD.
Division name	Research & Development Department
Zip code	504-0004
Address	2-40, Tamatsukuri 1-Chome, Chuo-Ku, Osaka-city, Osaka
TEL	072-800-1044
Email	t-kodama@jintan.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	MORISHITA JINTAN 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 Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
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	2017 Year 08 Month 27 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	Completed
Date of protocol fixation	2017 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 24 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032981