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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048553
Receipt No. 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 2022/08/02

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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
Email 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
Email clinic@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

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
Email 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
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 No longer recruiting
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 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055307

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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