UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051281 |
|---|---|
| Receipt number | R000058489 |
| Scientific Title | Effects of probiotics in healthy infants: a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2024/01/19 09:36:40 |
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Basic information
Public title
Effects of probiotics in healthy infants: a randomized control trail
Acronym
Effects of probiotics in healthy infants: a randomized control trail
Scientific Title
Effects of probiotics in healthy infants: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
Effects of probiotics in healthy infants: a randomized, double-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of probiotics for gut microbiota and health conditions in healthy infants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal environment, Biochemical measurements of stools, Defecation frequency and fecal condition, Health condition, Number of physician visits, Number of absences from nursery school or kindergarten
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest of probiotics for 8 weeks
Interventions/Control_2
Ingest of placebo for 8 weeks
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
| 5 | months-old | <= |
Age-upper limit
| 3 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy infants 5 months or older and younger than 3 years.
2) Infants with informed consent by representative family after receiving sufficient explanations in this study.
Key exclusion criteria
1) Infants with any severe congenital disease in blood, liver, heart, kidney, gastro-intestine and so on or who are suspected with immune disorder.
2) Infants with medication allergy, food allergy, or serious history of these.
3) Infants who regularly intake supplements containing Lactic acid bacteria and Bifidobacterium.
4) Infants who participated in other study within 1 month prior to obtaining informed consent, or those who are going to participate these study.
5) Infants considered to be unsuitable for enrollment by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Setsuko |
| Middle name | |
| Last name | Nakata |
Organization
Matsumoto City Hospital
Division name
Pediatrics
Zip code
390-1401
Address
4417-180 Hata, Matsumoto-shi, Nagano-ken, Japan
TEL
0263-92-3027
hospi@city.matsumoto.lg.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
General incorporated foundation Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F,1-18-1 Chuo, Matsumoto-shi, Nagano-ken, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
Matsumoto City Hospital
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
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
| 2023 | Year | 06 | Month | 07 | 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
100
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 | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058489
| 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 |
