UMIN-CTR Clinical Trial

Basic information
Public title	Effect of synbiotics on intestinal environment in healthy subjects
Acronym	Effect of synbiotics on intestinal environment
Scientific Title	Effect of synbiotics on intestinal environment in healthy subjects
Scientific Title:Acronym	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 with dietary fiber on intestinal environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	16S rRNA gene based metagenome analysis of gut microbiome
Key secondary outcomes	fecal bifidobacteria fecal short-chain fatty acids

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	100g beverage containing bifidobacterium GCL2505 (1.10^10 CFU/mL) and inulin (2g) (once a day for 4 weeks), observation period (3 weeks, post-treatment period (4 weeks)
Interventions/Control_2	100g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 4 weeks), observation period (3 weeks, post-treatment period (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	Subjects whose defecation frequency is more than 5 times per week
Key exclusion criteria	1. Subjects who regularly use intestinal and constipation drugs (including strong laxatives) 2. Subjects who are heavy drinkers or alcoholics. 3. Subjects who consume following foods (daily or during ingestion period): food containing lactic acid bacteria and bifidobacteria (fermented milk, beverages, supplement etc.,), prebiotics and oligosaccharides, food containing a large amount of dietary fiber (beverages, supplements etc.,) 4. Subjects who have a disease that requires emergency treatment, or have serious complications 5. Subjects who have a medical history of digestive diseases or surgeries affecting digestion and absorption 6. Subjects with food allergy 7. Subjects who are pregnant or plan to become pregnant , or breast-feeding during the study 8. Subjects who are participating in other clinical trials that intake/apply any foods or drugs.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Mawatari
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
Zip code	555-8502
Address	4-6-5, Utajima, Nishiyogogawa-ku, Osaka, Japan.
TEL	050-1745-4313
Email	takashi.mawatari@glico.com

Public contact
Name of contact person	1st name Takashi Middle name Last name Mawatari
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
Zip code	555-8502
Address	4-6-5, Utajima, Nishiyogogawa-ku, Osaka, Japan
TEL	050-1745-4313
Homepage URL
Email	takashi.mawatari@glico.com

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)

IRB Contact (For public release)
Organization	The Institutional Review Board of Glico Group
Address	2-4, Komatsubara-cho, Kita-ku, Osaka, Japan
Tel	+81-6-6477-8201
Email	ebisutani-kazuki@glico.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	2020 Year 10 Month 01 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043027
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043027
Number of participants that the trial has enrolled	40
Results	UniFrac distance analysis results showed a significant change in the gut microbiome composition of synbiotics group in comparison with that of placebo group. During the intervention period in synbiotics group, there was an increase in the abundance ratio of genus Bifidobacterium and Anaerostipes and a decrease in genus Clostridium. The quantitative PCR results showed that the total number of fecal Bifidobacterium significantly increased in only synbiotics group during the intervention period.
Results date posted	2020 Year 12 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unpublished
Participant flow	Number of Intention To Treat: 40 Number of Full Analysis Set: 33 Number of Per Protocol Set: 31
Adverse events	Nothing
Outcome measures	Primary outcomes 16S rRNA gene-based metagenome analysis of gut microbiome Secondary outcomes The total number of fecal Bifidobacteria The short-chain fatty acids concentrations
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 07 Month 31 Day
Anticipated trial start date	2019 Year 08 Month 21 Day
Last follow-up date	2019 Year 12 Month 06 Day
Date of closure to data entry	2020 Year 02 Month 10 Day
Date trial data considered complete	2020 Year 02 Month 27 Day
Date analysis concluded	2020 Year 09 Month 09 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 21 Day
Last modified on	2020 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043027