UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031414 |
|---|---|
| Receipt number | R000035852 |
| Scientific Title | Evaluation of the effects of drink-A containing lactic acid bacteria |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2018/09/10 15:46:39 |
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Basic information
Public title
Evaluation of the effects of drink-A containing lactic acid bacteria
Acronym
Evaluation of the effects of drink-A containing lactic acid bacteria
Scientific Title
Evaluation of the effects of drink-A containing lactic acid bacteria
Scientific Title:Acronym
Evaluation of the effects of drink-A 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
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
s-yoneda@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035852
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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