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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025098
Receipt No. 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

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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
Institute QOL RD Co.,Ltd.
Institute
Department

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
URL(English) https://upload.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


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