Status:
COMPLETED
The Effects of Omega-3 PUFAs on the Infant Microbiome and Immunity
Lead Sponsor:
University of British Columbia
Conditions:
Microbial Colonization
Infant Development
Eligibility:
All Genders
5-6 years
Brief Summary
Prenatal supplementation with fish oil, rich in omega-3 polyunsaturated fatty acids, is widely recommended in Canada. The aim of this observational, prospective cohort study is to determine the effect...
Detailed Description
During infancy, the gastrointestinal tract is colonized with microbiota, a community of microorganisms, which play a significant role in the development, regulation, and maintenance of immune function...
Eligibility Criteria
Inclusion
- All mothers of infants in the Okanagan Valley are invited to participate in the study between the first day of delivery to until solid food is introduced into the infant's diet.
- Healthy, full-term infants, who are predominantly breastfed by mothers who are or are not supplementing with fish oil. Mothers must also be healthy, i.e., asymptomatic and with no clinical indication of disease.
- To remain within the inclusion criteria for this study, participants will be expected to be consistent (i.e. maintain the same type and amount of omega-3 PUFA intake or no intake) with whichever supplementation group they have decided to join for the entirety of the breast milk and infant stool donation period. In other words, the investigators will be asking the participants not to switch from one group to another which would happen by changing their omega-3 PUFA supplementation patterns.
Exclusion
- Any infants who are ingesting juice or solid foods as part of their regular diet will be excluded from the study.
- Any infants who are clinically ill (fever, contagious diseases, or active diarrhea) will be excluded from the study.
- Any participants who decide to drastically change their omega-3 PUFA supplementation intake patterns (i.e. causing them to switch between study groups) will result in all subsequent samples to be excluded from the study.
Key Trial Info
Start Date :
January 22 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03297801
Start Date
January 22 2014
End Date
January 1 2017
Last Update
July 23 2024
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