UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049069 |
|---|---|
| Receipt number | R000055905 |
| Scientific Title | Study on the intestinal reachability of L. rhamnosus CRL1505 |
| Date of disclosure of the study information | 2024/06/29 |
| Last modified on | 2022/09/30 10:00:57 |
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Basic information
Public title
Study on the intestinal reachability of L. rhamnosus CRL1505
Acronym
Study on the intestinal reachability of L. rhamnosus CRL1505
Scientific Title
Study on the intestinal reachability of L. rhamnosus CRL1505
Scientific Title:Acronym
Study on the intestinal reachability of L. rhamnosus CRL1505
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify that Lactocaseibacillus. rhamnosus CRL1505 strain reaches the intestine alive
Basic objectives2
Others
Basic objectives -Others
Characterize the bacteria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of viable Lactocaseibacillus. rhamnosus CRL1505 strains in feces
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
Test food: Vegetable-fruit beverage containing Lactocaseibacillus. rhamnosus CRL1505 strain
Intake period: 1 week
Daily intake: 100g
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects will be healthy adults who have bowel movements at least 5 times per week.
Key exclusion criteria
1.Those who are regularly using intestinal or laxative medicines (including laxatives)
2.Those who have taken antibiotics within one month of the start of the study
3.Heavy drinkers of alcohol or alcohol dependents
4.Those who regularly consume fermented milk or lactic acid beverages containing lactobacilli or bifidobacteria and foods (supplements, etc.) containing large amounts of oligosaccharides and cannot stop during the study period.
5.Persons suffering from a disease requiring urgent treatment or having a serious complication
6.Those who have a gastrointestinal disease affecting digestion and absorption or a history of surgery
7.Those who have food allergies
8.Those who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
9.Those who are pregnant, intend to become pregnant during the study period, or are breast-feeding.
10.Persons in whom L. rhamnosus was detected as a commensal bacterium.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Chiba |
Organization
Ezaki Glico Co.Ltd
Division name
Institute of Product and Technology Development
Zip code
555-8502
Address
4-6-5 Utashima, Nishiyodogawa-ku, Osaka city, Osaka prefecture
TEL
050-1745-4299
shingo.chiba@glico.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ikari |
Organization
Ezaki Glico Co.Ltd
Division name
Institute of Product and Technology Development
Zip code
555-8502
Address
4-6-5 Utashima, Nishiyodogawa-ku, Osaka city, Osaka prefecture
TEL
050-1745-4299
Homepage URL
yuki.ikari@glico.com
Sponsor or person
Institute
Ezaki Glico Co.Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Glico Group Research Ethics Committee
Address
2-4 komatsubaratyo, kita-ku, Osaka city, Osaka prefecture
Tel
+81-6-6477-8793
Toshihiko.koike@glico.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
| 2024 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055905
