UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038798
Receipt No. R000044232
Scientific Title Effect of hyper protect capsule on viability of probiotics that reach to the large intestines
Date of disclosure of the study information 2019/12/06
Last modified on 2019/12/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of hyper protect capsule on viability of probiotics that reach to the large intestines
Acronym Viability of probiotics that encapsulated in hyper protect capsule to the large intestines
Scientific Title Effect of hyper protect capsule on viability of probiotics that reach to the large intestines
Scientific Title:Acronym Viability of probiotics that encapsulated in hyper protect capsule to the large intestines
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the functionality of the hyper protect capsule.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of ingested viable probiotic bacteria that reached to colon.
: The fecal number of viable bacteria ingested (Bifidobacterium)
Key secondary outcomes Analysis on gut microbiota by 16S metagenomic analysis
: Evaluation of the abundance of Bifidobacterium spp. in the feces

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test food A;Take a hyper protect capsules which contain Bifidobacterium in a package. (Single ingestion)
Interventions/Control_2 Test food B;Take a Bifidobacterium in a package. (Single ingestion)
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Healthy men and women of 20 years or older at the time of consent acquisition
(2) The number of Bifidobacterium spp.
(3) Person who the number of defecation per day is less than three times on average
(4) Persons with stool characteristics (Bristol scale) 3 or 4
(5) BMI has a standard range (18.5-25)
(6)A person who receives the explanation of the clinical trial in advance, understands the contents, agrees to the purpose, and obtains written consent from the person
Key exclusion criteria (1) Those who underwent open surgery within half a year of the trial start
(2) Those who have taken antibiotics for more than one week within half a year of the study start
(3) Persons who are allergic to the test food
(4) Those who plan to change their lifestyle significantly during the examination period
(5) Persons who are chronically prone to diarrhea (meaning stools with mud or watery stools)
(6) Patients with a history of significant liver dysfunction, renal dysfunction, or cardiovascular disease that is considered inappropriate for this study
(7) A person suspected of having a chronic or acute infection
(8) Those who are pregnant or nursing or who may be pregnant
(9) Those who participated in other clinical trials within the past 1 month
(10) Others who were judged by the study investigator to be inappropriate for this study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hirosato
Middle name
Last name Kawakami
Organization Morishita Jintan Co., Ltd.
Division name Health Care Product Department
Zip code 540-8566
Address 2-40,Tamatsukuri 1-chome, Chuo-ku, Osaka
TEL 06-6761-1131
Email h-kawakami@jintan.co.jp

Public contact
Name of contact person
1st name Mamiko
Middle name
Last name Kohno
Organization Morishita Jintan Co., Ltd.
Division name Health Care Product Department
Zip code 101-0043
Address 10, Kanda Tomiyamacho, Chiyoda-ku, Tokyo Ascend Kanda Building 6F
TEL 03-6206-8138
Homepage URL
Email m_kohno@jintan.co.jp

Sponsor
Institute Morishita Jintan Co., Ltd.
Institute
Department

Funding Source
Organization Morishita Jintan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of Animal Science, Department of Agriculture and Life Science, Kyoto Prefectural University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Social medical corporation sokuinkai kouyou Clinic Clinical Trial Review Committee
Address 3-9, Kouyou-cho, Kitahiroshima-shi, Hokkaido
Tel 011-372-3900
Email k-ohno@cli-creative.com

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
2019 Year 12 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 06 Day
Last follow-up date
2020 Year 03 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
2019 Year 12 Month 05 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.