UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058303 |
|---|---|
| Receipt number | R000066650 |
| Scientific Title | A Pre- and Post- Comparative Study on the Intestinal Delivery of Probiotics in Neonates with Two Different Dosages |
| Date of disclosure of the study information | 2025/06/29 |
| Last modified on | 2025/06/27 15:39:20 |
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Basic information
Public title
A Pre- and Post- Comparative Study on the Intestinal Delivery of Probiotics in Neonates with Two Different Dosages
Acronym
Clinical Trial on the Effects of Probiotics on Neonates
Scientific Title
A Pre- and Post- Comparative Study on the Intestinal Delivery of Probiotics in Neonates with Two Different Dosages
Scientific Title:Acronym
A Pre- and Post- Comparative Study on the Intestinal Delivery of Probiotics in Neonates with Two Different Dosages
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratively evaluate the intestinal delivery of probiotics, changes in the gut environment, and effects on health when healthy neonates consume test foods containing probiotic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection count and presence of probiotic strains from the test food in feces
Key secondary outcomes
1. Detection and presence of Bifidobacteria in the gut microbiota, and the count of Bifidobacteria in feces
2. Indicators related to the gut microbiota (occupancy rate and presence of each gut bacterium, diversity measures, etc.)
3. Frequency of bowel movements and stool characteristics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test foods containing high-dose probiotics until the one-month health check-up
Interventions/Control_2
Consumption of test foods containing low-dose probiotics until the one-month health check-up
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
| 1 | days-old | <= |
Age-upper limit
| 7 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Infants within 7 days of birth
2. Infants with a gestational age of 37 weeks or more but less than 42 weeks
3. Infants for whom written consent has been obtained from a legal guardian (or surrogate)
4. Infants assessed by the principal investigator as being in good health
Key exclusion criteria
1. Infants who do not plan to use formula milk during the study period
2. Infants who have or are at risk of having allergies to milk, soy, or neonatal/infant gastrointestinal allergies, making it difficult to feed them regular infant formula
3. Infants born from multiple births
4. Infants with a birth weight of less than 2,500 g or more than 4,000 g
5. Infants who have been administered probiotics or antibiotics
6. Infants with suspected or congenital severe diseases of the blood, liver, heart, kidneys, digestive system, or suspected immunodeficiency
7. Infants whose mothers have severe liver, kidney, cardiovascular, respiratory, endocrine, metabolic disorders, or psychiatric disorders
8. Infants who plan to use probiotics or prebiotics other than the test food during the study period
9. Infants deemed inappropriate as subjects by the principal investigator based on background, physical findings, examinations, physical tests, and clinical test results
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Itou |
Organization
Yokota Maternity Hospital
Division name
Head of Pediatrics
Zip code
371-0031
Address
1-5-22 Shimokoidecho, Maebashi-shi,Gunma
TEL
027-219-4103
ito@yokotamaternity.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management Department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yokoshima@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
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
横田マタニティーホスピタル Yokota Maternity Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066650
