UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033295 |
|---|---|
| Receipt number | R000037815 |
| Scientific Title | Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2020/01/06 09:04:33 |
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Basic information
Public title
Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial
Acronym
Fecal IgA in full-term infants who take Bifidobacterium trial
Scientific Title
Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial
Scientific Title:Acronym
Fecal IgA in full-term infants who take Bifidobacterium trial
Region
| Japan |
Condition
Condition
normal birth-weight and full-term infant
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this pilot trial is to calculate the sample size of the future main study. For this porpous, means and standard deviations of fecal IgA of two groups of infants, who use infant formula with or without Bifidobaterium.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal IgA level of infants
Key secondary outcomes
The number of Bifidobacterium bifidum in infant feces
Frequency of eczema in the study infants
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A group: The test formula is the infant formula containing heat-treated Bifidobacterim bifidum OLB6378
Interventions/Control_2
C group: The infant formula without Bifidobacterium bifidum OLB6378. It is indistinguishable from the test infantformula in appearance.
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
| Not applicable |
Age-upper limit
| 2 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
1. normal birth-weight (2,500 g <= birth-weight < 4,000 g ) infant and his/her mother
2. full-term (37 weeks <= gestational age < 42 weeks) infant and his/her mother
3. Signed consent form to participate in the study was obtained from the infant's mother as the legal representative after full explanation of this study and its ethical considerations to persons in parental authority.
Key exclusion criteria
1. infant with severe infection and his/her mother
2. infant with severe congenital abnormality and his/her mother
3. infant who is considered unsuitable subjects by the attending physician and his/her mother
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Shimojo |
Organization
Chiba University
Division name
Graduate School of Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL
043-226-2144
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Address
Tel
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
| 2019 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037815
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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