UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026885 |
|---|---|
| Receipt number | R000030843 |
| Scientific Title | Synergy effect when probiotics and prebiotics eaten together |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2018/08/21 12:10:18 |
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Basic information
Public title
Synergy effect when probiotics and prebiotics eaten together
Acronym
Synergy effect when probiotics and prebiotics eaten together
Scientific Title
Synergy effect when probiotics and prebiotics eaten together
Scientific Title:Acronym
Synergy effect when probiotics and prebiotics eaten together
Region
| Japan |
Condition
Condition
Constipation and intestinal dysbiosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the synergy effect when probiotics and prebiotics eaten together on stool frequency and intestinal microbiota in Japanese young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
change in stool frequency and intestinal microbiota after supplementation of test foods for 2 weeks
Key secondary outcomes
questionnaire survey about eating behavior and psychosomatic state
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily with 100ml water or milk for 2 weeks
Interventions/Control_2
intake of test food containing6.25g polydextrose daily with 100ml water or milk for 2 weeks
Interventions/Control_3
intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily and 6.25g polydextrose daily with 100ml water or milk for 2 weeks
Interventions/Control_4
intake of placebo food containing 6.25g dextrin daily with 100ml water or milk for 2 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) age more than 18 years old at consent and must be an Otsuma Women's University student
2) subjects understand the study procedures and agree to participate in the study by giving informed consent prior to the study
Key exclusion criteria
1) has history of cardiovascular diseases, liver disease, kidney disease digestive tract disease, respiratory disease, diabetes
2) has history of malignant disease or now on chronic disease therapy
3) takes drugs to treat disease
4) has history of drug and food allergy
5) has continuous intake of dietary fiber supplement (dietary fiber rich foods made with seaweed, konjak, psyllium etc) or whole grain cereals(whole grain wheat, brown rice, barley)
6) Females who are pregnant or lactating, and who could become pregnant during test period.
7) has smoking habit
8) Subjects who are participating the other clinical tests. Subjects who participated within 1-month prior to the current study and/or who plan to participate the other clinical tests.
9) has history of drug addiction or in therapy for drug addiction
10) Subject whose stool frequency is more than 5 days weekly
11) is not appropriate in the investigator's opinion
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichiro Aoe |
Organization
Otsuma Women's University
Division name
Fuculty of Home Economics
Zip code
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL
03-5275-6048
s-aoe@otsuma.c.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Sakanishi |
Organization
Danisco Japan Inc.
Division name
Nutrition and Health
Zip code
Address
Sanno Park Tower 11-1, Nagata-Cho 2-chome, Chiyoda-ku, 100-6111,Tokyo
TEL
03-5521-2427
Homepage URL
Hideki.Sakanishi@dupont.com
Sponsor or person
Institute
Otsuma Wonmen'w University
Fuculty of Home Economics
Institute
Department
Personal name
Funding Source
Organization
Danisco Japan Inc.
Nutrition and Health
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
大妻女子大学家政学部
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.oatext.com/pdf/IMM-4-306.pdf
Number of participants that the trial has enrolled
Results
The intake of polydextrose for 2 weeks increased the proportion of fecal Bacteroides. The combined intake of probiotics and prebiotics may increase stool amounts via increasing the proportion of Bacteroides among
the fecal microbiota.
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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030843
