UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028811 |
|---|---|
| Receipt number | R000032981 |
| Scientific Title | Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study |
| Date of disclosure of the study information | 2017/08/27 |
| Last modified on | 2020/10/06 09:50:45 |
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Basic information
Public title
Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study
Acronym
Effects of probiotics on intestinal environment in healthy adults
Scientific Title
Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study
Scientific Title:Acronym
Effects of probiotics on intestinal environment in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effect on intestinal environment by intervation with enteric seamless capsule containing probiotics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
* Analysis of intestinal microbiota
* Stool volume, shape, color, smell and feeling after defecation
* Constipation assessment scale
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take one pack of test-food-1 a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-2 a day for 2 weeks - Washout 4 weeks - Take one pack of control-food a day for 2 weeks
Interventions/Control_2
Take one pack of test-food-2 a day for 2 weeks - Washout 4 weeks - Take one pack of control-food a day for 2 weeks - Washout 4 weeks - Take one pack of test-food -1 a day for 2 weeks
Interventions/Control_3
Take one pack of control food a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-1 a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-2 a day for 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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 to 60years old. (A half of subjects aim to be men, and the generation of subjects aim to be dispersed.)
2) Subjects who defecate 3 to 5 times in a week.
3) Subjects who show low occupancy of Bifidobacterium in their feces.
4) Subjects who do not routinely consumed fermented foods, health foods which contain dietary fiber, and supplements, during the examination period.
5) Subjects who are explained about the study, show understanding of the study procedures, and show agreement with participating to the study by written informed consent prior to the study.
Key exclusion criteria
1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start.
2)Subjects who didn't take antibiotics within 6 month before test start.
3) Subjects who have allergy to test food.
4)Smokers
5)Subjects who are heavy drinkers of alcohol.
6) Subjects whose living together (consort or partner etc.) has plan to participate to the same clinical test.
7) Subjects who plan big change of lifestyle during test period.
8)Subjects with tendency of chronic diarrhea.
9)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
10)Subjects who suspected chronic or serious infectious disease.
11) Females who are pregnant (including the possibility of pregnancy) or are lactating.
12) Subjects who have participated to the other clinical test within 1 month before test start.
13) Subjects who have consumed medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment since 2 weeks before the day of advance examination.
14) Subject who cannot refrain from consumption of medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment during test period.
15) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kodama |
Organization
MORISHITA JINTAN CO.,LTD.
Division name
Research & Development Department
Zip code
504-0004
Address
2-40, Tamatsukuri 1-Chome, Chuo-Ku, Osaka-city, Osaka
TEL
072-800-1044
t-kodama@jintan.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MORISHITA JINTAN 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2017 | Year | 08 | Month | 27 | 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 | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | 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
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032981
