None
Conditions
Interventions
None listed
Sponsors
Miyake Women's Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria for provisional registration 1.Infants who are between 6 and 12 months of age at the time of stool collection 2.Infants whose mothers aged 20 years or older, who understand Japanese and are judged to have sufficient capacity to make decisions regarding the conduct of this study, are the guardians of the infants and whose consent to participate in the study has been obtained as the consensus of the persons with parental authority Selection criteria for definitive registration 1.Infants who could collect more than 10 g of stool for intestinal bacteria culture
Exclusion criteria
Exclusion criteria: Exclusion criteria for provisional registration 1.Children of mothers who did not agree to submit a written pledge for the blood tests (various virus tests) of their children's mothers 2.Children of mothers who have not consented to notification of a positive result in the child's viral test (saliva test and stool test) 3.Infants of mothers whose blood tests (various virus tests) are positive. 4.children who received a blood transfusion at birth 5.Children who received antibiotics from birth to the time consent was obtained. 6.Children who have not been weaned at the time of stool collection 7.Children with serious infectious disease 8.Children with severe congenital anomalies. 9.Children who are judged as inappropriate to participate in this study under the responsibility of the principal investigator. Exclusion criteria for definitive registration 1.children who tested positive for SARS-CoV2 in saliva test (virus test) 2.SARS-CoV2 positive in any stool test (virus test) 3.Children who are sick (fever over 37.5C, cough, nasal discharge, diarrhea, vomiting (except for vomiting after breastfeeding)) during the period of stool collection. 4.Children who received antibiotics from the time of obtaining consent until the completion of stool collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in intestinal microflora and components before and after incubation in a culture system | — |
Countries
Japan
Contacts
Public ContactArata Yoneda
Soiken Inc. Clinical Study Support Division
Outcome results
None listed