UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of synbiotics on intestinal environment in healthy adults.
Title of the study (Brief title)	Effect of synbiotics on intestinal environment.
Region	Japan

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

Objectives
Narrative objectives1	To verify the effect of bifidobacterium and dietary fiber on intestinal environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Quantification of fecal bifidobacteria using quantitative real-time polymerase chain reaction
Key secondary outcomes	16S rRNA gene based metagenome analysis of gut microbiome

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	Intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with inulin (2g) for 2 weeks - Washout 2 weeks, followed by intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with dextrin (2g) for 2 weeks
Interventions/Control_2	Intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with dextrin (2g) for 2 weeks - Washout 2 weeks, followed by intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with inulin (2g) for 2 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	Subjects whose defecation frequency is more than five times per week.
Key exclusion criteria	1. Subjects regularly use intestinal drugs and laxatives (including strong laxatives). 2. Subjects habitually consume higher amount of alcohol. 3. Subjects who took in food containing and bifidobacteria, and/or enhanced with oligosaccharide, dietary fiber during one week prior to the start of this study and can't stop intake during this study. 4. Subjects who change their life styles during this clinical trial 5. Subjects who have serious diseases requiring an urgent treatment, or who accept severe complication. 6. Subjects who have a medical history of diseases or surgeries affecting digestion, absorption and bowel movement. 7. Subjects who have allergy to test food. 8. Subjects who is pregnant or willing to be pregnant or breast-feeding during this study. 9. Subjects who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics.
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Mawatari
Organization	Ezaki Glico Co., Ltd
Division name	Institute of health science
Address	4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL	+81-6-6477-8425
Email	mawatari-takashi@glico.co.jp

Public contact
Name of contact person	Takashi Mawatari
Organization	Ezaki Glico Co., Ltd
Division name	Institute of health science
Address	4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL	+81-6-6477-8425
Homepage URL
Email	mawatari-takashi@glico.co.jp

Sponsor
Institute	Ezaki Glico Co., Ltd
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2019 Year 04 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 19 Day
Last follow-up date	2018 Year 04 Month 12 Day
Date of closure to data entry	2018 Year 05 Month 05 Day
Date trial data considered complete	2018 Year 05 Month 09 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The number of total bifidobacteria in feces was significantly increased during the probiotic and synbiotic intake periods compared with the observation period. There was no difference in the number of total bifidobacteria between the synbiotic intake period and the probiotic intake period (The average number of total bifidobacteria was higher in the symbiotic intake period compared to the probiotic intake period.). Moreover, the number of endogenous bifidobacteria was significantly higher in the synbiotic intake period compared to the probiotic intake period. By stratified analysis according to the number of B. lactis in the probiotic intake period (less than 5 X 10^9 cells/g), the number of total bifidobacteria, endogenous bifidobacteria and B. lactis was significantly higher in the symbiotic intake period compared to the probiotic intake period.
Other related information

Management information
Registered date	2018 Year 02 Month 19 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035820