UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052004 |
|---|---|
| Receipt number | R000059339 |
| Scientific Title | Cross-sectional study of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle |
| Date of disclosure of the study information | 2023/08/25 |
| Last modified on | 2024/09/04 15:41:37 |
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Basic information
Public title
Cross-sectional study of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Acronym
Cross-sectional study of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Scientific Title
Cross-sectional study of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Scientific Title:Acronym
Cross-sectional study of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of immunity parameters, Intestinal flora, Survey of background information on the subject
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects of both sexes aged 18 years or older.
Key exclusion criteria
1)Subjects with serious disorders on malignant tumors, respiratory disease, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system and metabolic system, or related severe past medical histories
2)Subjects with medication allergy, food allergy, or serious history of these
3)Subjects who are pregnant, under lactation or expecting to be pregnant during this study
4)Subjects with suffering from autoimmune diseases
5)Subjects who plan to use drugs that may affect immune response and intestinal flora (antiallergic agents, anti-inflammatory agents, antibiotics, drugs for digestive system treatment, diabetes drugs) from the time consent is obtained to the end of the study.
6)Subjects who plan to be vaccinated against influenza, COVID-19, or other infectious diseases from the time consent is obtained to the end of the study.
7)Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tanaka |
Organization
MORINAGA MILK INDUSTRY CO.,LTD.
Division name
Innovative Research Institute R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-Pref
TEL
046-252-3067
m_tanaka@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Nishimura |
Organization
MORINAGA MILK INDUSTRY CO.,LTD.
Division name
Innovative Research Institute R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-Pref
TEL
046-252-3067
Homepage URL
tatsuki-nishimura871@morinagamilk.co.jp
Sponsor or person
Institute
MORINAGA MILK INDUSTRY CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.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
| 2023 | Year | 08 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory evaluation of host immune responses stimulated by bifidobacteria and lactobacilli in relation to intestinal microbiota and lifestyle
Management information
Registered date
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059339
