UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055388 |
|---|---|
| Receipt number | R000063202 |
| Scientific Title | Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in children and their parents on intestinal IgA levels: a pilot study |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/03/27 11:20:00 |
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Basic information
Public title
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in children and their parents on intestinal IgA levels: a pilot study
Acronym
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in children and their parents on intestinal IgA levels: a pilot study
Scientific Title
Effect of bifidobacteria (heat-killed B. bifidum OLB6378) intervention in children and their parents on intestinal IgA levels: a pilot study
Scientific Title:Acronym
Effect of bifidobacterial intake on intestinal IgA levels.
Region
| Japan |
Condition
Condition
healthy children and their parents
Classification by specialty
| Gastroenterology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects on the intestinal IgA production increase by 2 weeks intervantion of heat-killed B. bifidum OLB6378 in children and their adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
IgA in stools of children on 7, 14 , 28, 42 day from the begining of intake (Stratified analysis by bifidobacteria count in stool)
Key secondary outcomes
1. IgA in stools of children on 7, 14 , 28, 42 day from the begining of intake (No stratified analysis by bifidobacteria count in stool)
2. IgA in stools of adults on 7, 14 , 28, 42 day from the begining of intake
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bifidobacteria-containing foods to children, for 14 days, 100 mL/day
Interventions/Control_2
Bifidobacteria-containing foods to adults, for 14 days, 100 mL/day
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
| 12 | months-old | <= |
Age-upper limit
| 36 | months-old | > |
Gender
Male and Female
Key inclusion criteria
(1) The infant's parent has been fully informed of the purpose and content of the study, is competent to consent, has fully understood the purpose and content of the study, has volunteered to participate of his/her own free will, and has given written consent for both the infant's and his/her own participation in the study.
(2) The infant must be between 1 and 3 years of age as of September 1, 2024.
(3) The infant have not had a serious illness or major surgery in the past.
Key exclusion criteria
(1) The child or his/her parent is allergic to milk.
(2) The child or his/her parent is lactose intolerant.
(3) The child has had no defecation for more than 3 days at least twice in the past month.
(4) The child has been prescribed antibacterial or laxative medication in the past month
(5) The child has been consuming food containing Bifidobacterium bifidum OLB6378 at least twice a week for the past month.
(6) The child is participating in another study as of the date of consent
(7) The child has been abroad for at least one consecutive year in the past and has been back home for less than one month as of the date of consent.
(8) The child's siblings are participating in this study.
(9) The parent of children is under 18 years of age.
(10) Any cases in which the principal investigator determines that the child or his/her parent is inappropriate as a research subject.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Chiharu |
| Middle name | |
| Last name | Tsutsumi |
Organization
Sagami Women's University
Division name
Department of Nutrition and Health
Zip code
252-0307
Address
2-1-1, Bunkyo, Minami-ku, Sagamihara, Kanagawa
TEL
042-742-201
tsutsumi_chiharu@isc.sagami-wu.ac.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Sato |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs 3G
Zip code
192-0919
Address
1-29-1, Nanakuni, Hachioji, Tokyo
TEL
042-632-5848
Homepage URL
project_OLB6378@meiji.com
Sponsor or person
Institute
Sagami Women's University
Institute
Department
Personal name
Tsutumi Chiharu
Funding Source
Organization
The Food Science Institute Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Holdings Co., Ltd., Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee for Research Involving Human Subjects at Sagami Women's University
Address
2-1-1, Bunkyo, Minami-ku, Sagamihara, Kanagawa
Tel
042-742-2546
tsutsumi_chiharu@isc.sagami-wu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-021
Org. issuing International ID_1
Meiji Holdings Co., Ltd
Study ID_2
2024-007
Org. issuing International ID_2
Meiji Co., Ltd
IND to MHLW
Institutions
Institutions
明治イノベーションセンター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | 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
36
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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063202
