UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047514 |
|---|---|
| Receipt number | R000054188 |
| Scientific Title | Relationship between the probiotics and infant health: a prospective cohort study |
| Date of disclosure of the study information | 2022/04/19 |
| Last modified on | 2023/10/19 09:07:10 |
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Basic information
Public title
Relationship between the probiotics and infant health: a prospective cohort study
Acronym
Relationship between the probiotics and infant health: a prospective cohort study
Scientific Title
Relationship between the probiotics and infant health: a prospective cohort study
Scientific Title:Acronym
Relationship between the probiotics and infant health: a prospective cohort study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy of intake of probiotics during neonatal period for health and development of term infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of allergy symptoms.
Scores of development tests.
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
| 3 | months-old | <= |
Age-upper limit
| 8 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1) infants who participated in 'Effects of the probiotics for healthy infants: a randomized control trail'
2) infants less than 8 months old.
3) infants whose mother or father provide informed consent for participation.
Key exclusion criteria
infants considered to be unsuitable for enrollment in the opinion of the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Tsuno |
Organization
Matsumoto City Hospital
Division name
pediatrics
Zip code
390-1401
Address
4417-180 Hata, Matsumoto-shi, Nagano-ken, 390-1401, Japan
TEL
0263-92-3027
hospi@city.matsumoto.lg.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Tsuno |
Organization
Matsumoto City Hospital
Division name
pediatrics
Zip code
390-1401
Address
4417-180 Hata, Matsumoto-shi, Nagano-ken, 390-1401, Japan
TEL
0263-92-3027
Homepage URL
hospi@city.matsumoto.lg.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk industry
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
Research Ethics Committee of Matsumoto City Hospital
Address
4417-180 Hata, Matsumoto-shi, Nagano-ken, 390-1401, Japan
Tel
0263-92-3027
hospi@city.matsumoto.lg.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 19 | 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
89
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
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Infants who were treated with probiotics during the neonatal period will be included and their health effects will be evaluated.
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054188
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
