UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025098
Receipt number R000028862
Scientific Title Evaluation of the effects of the fermented milk drink-1 containing Lactobacillus casei NY1301
Date of disclosure of the study information 2016/12/26
Last modified on 2017/07/05 13:42:43

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Basic information

Public title

Evaluation of the effects of the fermented milk drink-1 containing Lactobacillus casei NY1301

Acronym

Evaluation of the effects of the fermented milk drink-1

Scientific Title

Evaluation of the effects of the fermented milk drink-1 containing Lactobacillus casei NY1301

Scientific Title:Acronym

Evaluation of the effects of the fermented milk drink-1

Region

Japan


Condition

Condition

Subjects who have a tendency to be constipated

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of the fermented milk drink containing Lactobacillus casei NY1301 on bowel movement of subjects who have a tendency to be constipated

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency, fecal amount

Key secondary outcomes

Fecal shape, fecal color, feelings after defecation, analysis of intestinal microflora


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

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the fermented milk drink for 2 weeks

Interventions/Control_2

Intake of the placebo drink 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

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Males and females from 20 to 70 years-old
(2)Subjects who have a tendency to be constipated defecate two to five times a week
(3)Subjects undergoing none of medical treatments
(4)Subjects eat regularly

Key exclusion criteria

(1)Subjects with a serious disease
(2)Subjects have a medical history or a surgical history of digestive diseases
(3)Subjects allergic to a specific drug or food
(4)Subjects work alternative or midnight shifts
(5)Subjects never be able to stop intaking foods or drinks which improve constipation during study,such as foods containing lactic acid bacteria,bifidobacteria,natto bacteria,oligosaccharides,dietary fibers and/or other health foods including food for specified health use
(6)Subjects taking any kinds of drugs affect this study(constipation drugs,intestinal drugs,etc.)
(7)Subjects drink alcohol over 500mL in terms of beer per day
(8)Subjects smoke over 20 cigarettes per day
(9)Subjects drawn blood over 200mL last 1 month,or over 400mL last 3 months
(10)Subjects allergic to samples in this study
(11)Pregnants,lactating women or who is going to be pregnant
(12)Subjects who have participated in the other clinical studies
(13)Subjects judged as unsuitable for the study by the principal investigator for other reasons

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Moriyama

Organization

Kanazawabunko Hospital

Division name

Vice president

Zip code


Address

2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama city,Kanagawa,Japan

TEL

045-785-3311

Email

nagashima@kanabun-hp.jp


Public contact

Name of contact person

1st name
Middle name
Last name Soichi Yoneda

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code


Address

2-14-1,Nihonbashi,Chuo-ku,Tokyo,

TEL

03-6386-8809

Homepage URL


Email

s-yoneda@qol-rd.co.jp


Sponsor or person

Institute

QOL RD 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

金沢文庫病院(神奈川県)、上尾甦生病院(埼玉県)、白岡中央総合病院(埼玉県)、さがみリハビリテーション病院(神奈川県)、メディカルトピア草加病院(埼玉県)、桜ヶ丘中央病院(神奈川県)、横浜なみきリハビリテーション病院(神奈川県)、浅草病院(東京都)、カイユウ診療所(東京都)、武蔵境クリニック(東京都)、日本橋ハートクリニック(東京都)、八木病院(東京都)、戸田中央総合病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 26 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

2016 Year 10 Month 27 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 26 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

2016 Year 12 Month 01 Day

Last modified on

2017 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028862


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name