UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031101 |
|---|---|
| Receipt number | R000035513 |
| Scientific Title | A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults. |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2019/06/06 16:03:30 |
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Basic information
Public title
A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults.
Acronym
A confirmation study for improving effects of probiotics and synbiotics on intestinal environment.
Scientific Title
A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults.
Scientific Title:Acronym
A confirmation study for improving effects of probiotics and synbiotics on intestinal environment.
Region
| Japan |
Condition
Condition
Subjects with a tendency for constipation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of bifidobacterium GCL2505 and bifidobacterium GCL2505 with inulin on gut bifidobacteria and intestinal environment of subjects with a tendency for constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fecal bifidobacteria
Key secondary outcomes
defecation days, defecation frequency
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test drink containing bifidobacterium GCL2505 (concentration of 1 X 10^10 CFU) for 2 weeks - Washout 2 weeks.
Interventions/Control_2
Intake of test drink containing bifidobacterium GCL2505 (concentration of 1 X 10^10 CFU) and inulin (2g) for 2 weeks - Washout 2 weeks.
Interventions/Control_3
Intake of placebo drink (not containing bifidobacterium GCL2505 and inulin) for 2 weeks - Washout 2 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose defecation frequency is no fewer than 2, nor more than 5.
2. Subjects who usually have three meals a day.
Key exclusion criteria
1. Subjects who regularly use intestinal drugs and laxatives (including strong laxatives).
2. Subjects who regularly intake healthy food to relieve constipation.
3. Subjects who use medicine such as antibiotics that affect digestion and absorption.
4. Subjects who can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during this study.
5. Subjects who have allergic to food.
6. Subjects who have serious diseases requiring an urgent treatment, or who accept severe complication.
7. Subjects who has a medical history of diseases or surgeries affecting digestion, absorption and bowel movement.
8. Subjects are judged unsuitable for this study based on subject questionnaire.
9. Subjects who is pregnant or willing to be pregnant or breast-feeding during this study
10. Subjects who has a current or history of drug dependence and/or alcoholism.
11. Subjects who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics, or willing to be that
12. Subjects who are judged unsuitable for this study by principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo, Japan
TEL
+81-3-3452-3381
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Co., Ltd
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
+81-3-3542-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Ethical Committee of Shinagawa Season Terrace Health Care Clinic
Address
1-2-70, Konan, Minato-ku, Tokyo, Japan
Tel
+81-3-3452-3381
tomohiro_kogo@sempos.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 30 | 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 | 22 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 26 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035513
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