UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028811
Receipt number R000032981
Scientific Title Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study
Date of disclosure of the study information 2017/08/27
Last modified on 2020/10/06 09:50:45

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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 or person

Institute

CPCC Company Limited

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name