UMIN-CTR Clinical Trial

Public title

Dose-finding study of drink-D containing lactic acid bacteria:A randomized, double blinded, placebo controlled study

Acronym

Dose-finding study of drink-D containing lactic acid bacteria

Scientific Title

Dose-finding study of drink-D containing lactic acid bacteria:A randomized, double blinded, placebo controlled study

Scientific Title:Acronym

Dose-finding study of drink-D containing lactic acid bacteria

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to verify the effect
of drink-D containing lactic acid bacteria on defecation and intestinal environment for subjects with constipation tendency

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation frequency,Defecation days.
Evaluate two weeks after starting ingestion.

Key secondary outcomes

Stool output, Fecal properties,
Intestinal flora (Real-Time PCR)

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of high-dose test product for 2 consecutive weeks

Interventions/Control_2

Ingestion of medium-dose test product for 2 consecutive weeks

Interventions/Control_3

Ingestion of placebo for 2 consecutive weeks

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 who answered that the usual defecation frequency was 2 to 5 times per week in the questionnaire
(3)Subjects with a tendency for constipation at 2 to 5 times of defecation per week during screening period

Key exclusion criteria

(1)Subjects who cannot restrict the use of medicines or health foods that may influence their bowel movement s after informed consent
(2)Subjects visiting the hospital for diseases related bowel movements and using drugs,or using commercial laxative
(3)Subjects currently undergoing treatment with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy)
(4)Subjects with diseases(irritable enteritis,ulcerative colitis, etc.) affecting bowel movement or have a history of these diseases
(5)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(7)Subjects need to be on medication or have a history of medication for serious diseases.
(8)Subjects have possibilities to develop an allergy to the test product
(9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(11)Subjects who have participated in other clinical studies
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(13)Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Jiro Saito

Organization

Medical Station Clinic

Division name

None

Zip code

Address

3-12-8 Takabann, Meguro-ku, Tokyo, Japan

TEL

03-6452-2712

Email

info@med-station.jp

Name of contact person

1st name
Middle name
Last name	Chiharu Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

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

TEL

03-5459-5329

Homepage URL

Email

c.goto@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

Nissin York 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

09

Month

10

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

08

Month

24

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

11

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

09

Month

08

Day

Last modified on

2018

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033230