healthy children and their parents
Conditions
Interventions
Bifidobacteria-containing foods to children, for 14 days, 100 mL/day
Bifidobacteria-containing foods to adults, for 14 days, 100 mL/day
Sponsors
Sagami Women's University
Meiji Holdings Co., Ltd., Meiji Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgA in stools of children on 7, 14 , 28, 42 day from the begining of intake (Stratified analysis by bifidobacteria count in stool) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKeigo Sato
Meiji Holdings Co., Ltd. Wellness Science Labs 3G
Outcome results
None listed