UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036440 |
|---|---|
| Receipt number | R000041522 |
| Scientific Title | Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2023/04/11 11:18:11 |
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Basic information
Public title
Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial
Acronym
Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial
Scientific Title
Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial
Scientific Title:Acronym
Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial
Region
| Japan |
Condition
Condition
infants who were born within gestational age of 35 weeks or less and were treated in and discharged from NICU or GCU
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate the efficacy of heat-killed K15 to prevent virus respiratory tract infections in premature infants who were treated in and discharged from NICU or GCU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
duration of fever episodes
Key secondary outcomes
1. frequency of respiratory tract infection
2. severity of respiratory tract infection
3. frequency of Respiratory syncytial virus (RSV) infection diagnosed by physician
4. Severity of respiratory disorder
5. Serum IgG, IgA, IgM before and after treatment
6. side effects related to K15 administration
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administer 4.6mg of K15 (adjusted to total 100mg with dextrin) once daily from the first outpatient visit to 12 months orally or by tube
Interventions/Control_2
administer placebo (100mg of dextrin) once daily from the first outpatient visit to 12 months orally or by tube
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) infants who were born within gestational age of 35 weeks or less and were treated in and discharged from NICU or GCU
2) Signed consent form to participate in the study was obtained from the infant's legal representative (guardian) by her/his free will after full explanation of this study
Key exclusion criteria
1) infants who have allergy to Lactobacillus preparation or products derived from soy
2) infants who have congenital heart defect, severe respiratory disorder, chromosomal abnormality, or primary immunodeficiency
3) infants who are considered unsuitable to participate in this study by attending physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Chiba University
Division name
Graduate School of Medicine
Zip code
260-0856
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 | Hiroki |
| Middle name | |
| Last name | Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
101-0052
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo. 101-0052, JAPAN
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
Kikkoman Corporation
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
Chiba University Hospital Ethics Review Board
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, JAPAN
Tel
043-222-7171
chibacrc@mac.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
| 2019 | Year | 04 | Month | 08 | 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
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041522
| 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 |
