UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031846 |
|---|---|
| Receipt number | R000034278 |
| Scientific Title | Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces. |
| Date of disclosure of the study information | 2018/03/23 |
| Last modified on | 2018/03/22 18:51:40 |
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Basic information
Public title
Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Acronym
Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Scientific Title
Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Scientific Title:Acronym
Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Region
| Japan |
Condition
Condition
healthy poeple and mild constipation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Super Orient 39 Plant fermented food intake 2 g per day for 2 weeks and measure the change of spoilage products indole, skatole, phenol, paracresol in feces.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of spoilage products indole, skatole, phenol, paracresol in feces
Key secondary outcomes
Questionnaire survey on odor in feces was carried out.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The first period,The subjects intake super orient39 plant fermented food 2g per day for 2weeks. We checked their bloods and feces in baseline and 2weeks later.
After 4weeks wash out period,the second period started. The subject didn't intake the food for 2weeks. We checked thier bloods and feces baseline and 2weeks later.
Interventions/Control_2
The first period,The subject didn't intake the food for 2weeks. We checked thier bloods and feces baseline and 2weeks later.
After 4weeks wash out period,the second period started. The subjects intake super orient39 plant fermented food 2g per day for 2weeks. We checked their bloods and feces in baseline and 2weeks later.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The person didn't have serious disease.
2.The person was not taking supplments to improve the bowel movement.
3.It is possible to maintain the day-to-day life.
4.The person who is permitted by the doctor.
Key exclusion criteria
1.The person have serious disease.
2.The person have food allergy.
3.Pregnant and brest-feeding woman
4.The person who isn't permitted by the dicotor.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tnaka |
Organization
kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3,Komagome,Toshima,Tokyo.
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kmachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome,Toshima,Tokyo
TEL
03-3918-6181
Homepage URL
Clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
International Food 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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 13 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034278
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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