UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038798 |
|---|---|
| Receipt number | 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 | 2024/01/10 23:08:47 |
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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
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
m_kohno@jintan.co.jp
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Animal Function Science Laboratory, Department of Applied Biological Sciences, Faculty of Agriculture,Setsunan 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
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044232
