UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031367
Receipt number R000035820
Scientific Title Effect of synbiotics on intestinal environment in healthy adults.
Date of disclosure of the study information 2019/04/30
Last modified on 2018/11/14 11:21:53

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Basic information

Public title

Effect of synbiotics on intestinal environment in healthy adults.

Acronym

Effect of synbiotics on intestinal environment.

Scientific Title

Effect of synbiotics on intestinal environment in healthy adults.

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 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

1st name
Middle name
Last name Takashi Mawatari

Organization

Ezaki Glico Co., Ltd

Division name

Institute of health science

Zip code


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

1st name
Middle name
Last name Takashi Mawatari

Organization

Ezaki Glico Co., Ltd

Division name

Institute of health science

Zip code


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 or person

Institute

Ezaki Glico Co., Ltd

Institute

Department

Personal name



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


Address


Tel


Email



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


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

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.

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 02 Month 19 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name