UMIN-CTR Clinical Trial

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