UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029054
Receipt number R000033230
Scientific Title Dose-finding study of drink-D containing lactic acid bacteria:A randomized, double blinded, placebo controlled study
Date of disclosure of the study information 2017/09/10
Last modified on 2018/10/31 09:09:20

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Basic information

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

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

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

Key secondary outcomes

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


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Nissin York 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


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

2017 Year 09 Month 10 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 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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name