UMIN-CTR Clinical Trial

Public title

The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study

Acronym

The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function

Scientific Title

The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study

Scientific Title:Acronym

The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function

Region

Japan

Condition

Individuals with a tendency for constipation

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In order to investigate the efficacy of the intake of the functional food on individuals with constipation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

defecation frequency, stool output

Key secondary outcomes

defecation days, fecal condition

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

intake of a test food containing with lactobacillus for 2 consecutive weeks

Interventions/Control_2

intake of a placebo for 2 consecutive 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week

Key exclusion criteria

(1) Subjects who routinely takes foods or medicines containing of Lactobacillus
(2) Subjects who routinely takes foods or medicines containing of Bacillus subtilis var. natto
(3) Subjects who routinely takes foods or medicines affecting the test result
(4) Subjects having diseases affecting bowel movement or a history of these diseases
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects who has asthma or the possibility of asthma
(7) Subjects who is employed on a pre-dawn shift or on night duty more than 2 times
(8) Subjects who is planned to go overseas
(9) Subjects who has treatment or a history of serious disease
(10) Subjects who has treatment of disease
(11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test
(12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(15) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takehisa Kumagai

Organization

KAMEDA SEIKA CO., LTD.

Division name

RICE RESEARCH INSTITUTE

Zip code

Address

3-1-1 Kameda Kogyo Danchi, Konan-ku, Niigata City, Niigata

TEL

025-382-8879

Email

t_kumagai@sk.kameda.co.jp

Name of contact person

1st name
Middle name
Last name	Shingo Yamamichi

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

s.yamamichi@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

KAMEDA SEIKA CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

11

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

19

Day

Last modified on

2017

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031399