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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031413
Receipt No. R000035853
Scientific Title Evaluation of the effects of drink-B containing lactic acid bacteria
Date of disclosure of the study information 2018/04/03
Last modified on 2018/09/10

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Basic information
Public title Evaluation of the effects of drink-B containing lactic acid bacteria
Acronym Evaluation of the effects of drink-B containing lactic acid bacteria
Scientific Title Evaluation of the effects of drink-B containing lactic acid bacteria
Scientific Title:Acronym Evaluation of the effects of drink-B containing lactic acid bacteria
Region
Japan

Condition
Condition Subjects who have a tendency to be constipated
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirm the effectiveness of the beverage containing Lactobacillus casei NY1301 strain on constipated adults'intestine for 2weeks.
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,Intestinal flora(Real-Time PCR),Fecal ammonia content,Fecal pH,Fecal moisture content

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of drink containing lactic acid bacteria for 2 weeks
Interventions/Control_2 Intake of 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)Subjects from 20 to 69 years-old
2)Subjects with constipation tendency (their defecation frequency is 2 to 4 times a week in the past about 3 months,and constipation is not so severe)
3)Subjects undergoing none of medical treatments
4)Subjects who can record daily logs during the designated period
5)Subjects who can record diet records on specified days
6)Subjects who can visit during the designated period
7)Subjects who can collect and submit a sample during the designated period
Key exclusion criteria 1)Subjects with serious liver disease,renal/heart disease,organ disorder,diabetes,food allergy,gastrointestinal disease,other serious diseases
2)Subjects have a medical history or a surgical history of digestive diseases
3)Subjects allergic to a specific drug or food
4)Subjects allergic to samples in this study
5)Subjects with a large influence on defecation during menstruation or in poor physical condition
6)Pregnants,lactating women or who is going to be pregnant during study
7)Subjects drawn blood over 200mL last 1 month,or over 400mL last3 months before consent acquisition date
8)Subjects scheduled for medical examination during study
9)Subjects who can't maintain everyday life habits
10)Subjects who do not ingest three meals a day
11)Subjects who do not ingest beverages at breakfast
12)Subjects working at night or in rotation
13)Subjects with a several variation of the amount of diet or movement
14)Subjects drink alcohol over 500mL in terms of beer per day
15)Subjects smoke over average 20 cigarettes per day
16)Subjects who have any kinds of drugs affect this study (constipation drugs,intestinal drugs,antibiotics,etc.)
17)Subjects who can not refrain from using health foods,during the study
18)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
19)Subjects who can not take the test food as instructed
20)Subjects who have participated in the other clinical studies
21)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Fujisawa
Organization Ageo Central Second Hospital
Division name Director
Zip code
Address 421-1 , Jitougata, Ageo-shi, Saitama
TEL 048-781-1101
Email susumu.hosonuma@achs.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Yoneda
Organization APO PLUS STATION CO., LTD.
Division name CRO Department Food Test Division
Zip code
Address 2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL 03-6386-8809
Homepage URL
Email s-yoneda@apoplus.co.jp

Sponsor
Institute APO PLUS STATION 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 上尾中央第二病院(埼玉県)、白岡中央総合病院(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)、笛吹中央病院(山梨県)、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)、金内メディカルクリニック(東京都)、クロス病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 03 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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 03 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
2018 Year 02 Month 22 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035853

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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