UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043672 |
|---|---|
| Receipt number | R000049871 |
| Scientific Title | A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract. -Single group before-after test- |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/09/17 20:26:16 |
* 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
Study on the arrival of live bifidobacteria in the gastrointestinal tract. -Single group before-after test-
Acronym
Study on the arrival of live bifidobacteria in the gastrointestinal tract.
Scientific Title
A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract. -Single group before-after test-
Scientific Title:Acronym
A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of survival of bifidobacteria in human feces before and after ingestion of acid-resistant bifidobacteria supplement
Basic objectives2
Others
Basic objectives -Others
Verification of supplement on acid resistance processing technology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of certain live Bifidobacterium in feces.
Time: Before and after the intervention (0day, 14days)
Key secondary outcomes
Viable cell count of certain Bifidobacterium in feces
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium-containing acid-resistant preparation
Intervention period:14days
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy men and women 20 to 64 years old
2.Subjects who have defecation every day and can collect stool at the designated date and time
3.Subjects who have received sufficient explanation about the purpose and content of the exam, have the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the exam in writing.
Key exclusion criteria
1. Subjects who tend to have loose stools or constipation
2. Subjects who cannot stop the intake of foods containing certain Bifidobacterium from the screening test to the end of the 2-week test.
3. Subjects who are taking drugs that affect digestion and absorption, such as antibiotics
4. Subjects who cannot stop the intake of medicines, quasi-drugs, and health foods that affect the test during the test period.
5. Subjects with food allergies
6. Subjects who consume a large amount of alcohol on a daily basis
7. Subjects who have urgent medical treatment or have serious complications
8. Subjects with digestive disorders or surgical history that affect digestion and absorption and defecation
9. Subjects with a history of irritable bowel syndrome or a current medical history
10. Subjects background Persons who are judged to be inappropriate as subjects based on the answers to the questionnaire
11. Pregnant, willing to become pregnant during the exam, breastfeeding
12. Subjects with a history of drug dependence, alcohol dependence, or current medical history
13. Subjects who have participated in or are willing to participate in tests that take other foods or use drugs, and tests that apply cosmetics and drugs
14. Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
品川シーズンテラス健診クリニック/Shinagawa Season Terrace Health Care Clinic
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | 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
| 2021 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 10 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049871
