UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048553 |
|---|---|
| Receipt number | R000055307 |
| Scientific Title | Influence on enteral environment and physical condition by the intake of "plant fermentation extract combination food KTH-01" |
| Date of disclosure of the study information | 2022/08/05 |
| Last modified on | 2022/11/30 15:05:07 |
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Basic information
Public title
Influence on enteral environment and physical condition by the intake of "plant fermentation extract combination food KTH-01"
Acronym
Influence on enteral environment and physical condition by the intake of "plant fermentation extract combination food KTH-01"
Scientific Title
Influence on enteral environment and physical condition by the intake of "plant fermentation extract combination food KTH-01"
Scientific Title:Acronym
Influence on enteral environment and physical condition by the intake of "plant fermentation extract combination food KTH-01"
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects take about 0.5g test foods every day in four weeks. We check questionnaire survey of constipation conditions and the enterobacterial flora inspection at baseline and after.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We observe a bowel movement improvement effect by questionary survey after the intake for four weeks.
In addition, we observe enterobacterial flora and observe the change using 16SrRNA gene analytical method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
At the baseline and after the examination, we check blood and faeces test and the questionnaire survey of constipation conditions. The subjects takes two capsules(test food 0.5g) per day while 4 weeks.
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1).Healthy adult who do not have any serious disease.
2)Gender free.
3)The person who is younger than 75 years old.
4)The tendency to constipation.
5)Did not use any drugs in one month.
6)The person who can maintain an everyday lifestyle.
7)The examination responsibility doctor accepted the participation of the person.
Key exclusion criteria
1)The person who takes medicines every day.
2)The person who has serious diseases (heart disease, liver disease, renal disease, cancer, allergy to food, drug allergy, mental disease).
3)The person who use a laxative, aperient, a supplement, healthy tea regularly and use many it.
4)The person who has food allergy (apple or yam) or drug allergy.
5)Pregnant woman, under the nursing woman.
6)The person who participates in another human clinical study. The one where one month does not pass after another human clinical study participation.
7)The examination responsibility doctor dose not accepted the participation of the person.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ishihara |
Organization
Kagawa Nutrition University
Division name
KNU Nutrition Clinic
Zip code
170-8481
Address
3-24-3,Komagome,Toshimaku,Tokyo.
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
KNU Nutrition Clinic
Zip code
170-8481
Address
3-24-3, Komagome,Toshima, Tokyo
TEL
0339186181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kotohogi Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kugawa Nutritison University
Address
3-9-21,Chiyoda,Sakado,Saitama
Tel
049-283-2131
clinic@eiyo.ac.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
| 2022 | Year | 08 | Month | 05 | 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
12
Results
1.The stool frequency and the stool output significantly increased.
2.JPAC-QOL;queitionnaire survey of constipation conditions shows that interest/worry, the physical discomfort, the psychic unpleasantness significantly decreased. In addition, the satisfaction significantly rose.
3.By the examination of enterobacterial flora, the share of lactic acid production bacteria rose.
Results date posted
| 2022 | Year | 11 | Month | 30 | Day |
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
Main results already published
Date of protocol fixation
| 2022 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055307
