The Effects of Omega-3 PUFAs on the Infant Microbiome and Immunity

NCT ID: NCT03297801

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-22
• Study Completion Date: 2017-01-31

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 effects of maternal fish oil supplements on the development of their infants' gut microbiota and immunity.

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 functions. Fish oil, rich in n-3 polyunsaturated fatty acids (PUFA), are thought to be anti-inflammatory and consequently may increase susceptibility to infection by hindering their body's ability to produce an adequate inflammatory response in defense against infectious disease. Currently, women in Canada are supplementing their diets with n-3 PUFA during gestation and lactation despite their being conflicting clinical evidence regarding the beneficial effects on infant development. It is currently unknown how maternal fish oil supplementation impacts the offspring's gut microbiota and immune functions. Considering that diet influences microbiota and maternal microbiota is passed from mother to infant, the investigators hypothesize that maternal fish oil supplementation will affect the participants' infant gut microbiota and immunity.

This study will evaluate the effects of postnatal n-3 PUFA supplementation in breast milk on the fecal microbiome in infants over a six-month period. The investigators will analyze the fecal microbiome of infants born to mothers in the fish oil and non-fish oil groups via next generation sequencing. As short-chain fatty acids (SCFA) are produced by gut bacteria and affect immunity, the investigators will analyze SCFA in stool through gas chromatography. Markers of inflammation like fecal calprotectin and sIgA in stool samples will also be identified.

Conditions

Microbial Colonization; Infant Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fish oil group

Women who chose to supplement with fish oil, rich in omega-3 polyunsaturated fatty acids, during gestation or lactation.

Fish oil supplements

Intervention Type: DIETARY_SUPPLEMENT

Women who chose to supplement with fish oil during gestation or lactation.

No fish oil group

Women who chose not to supplement with fish oil during gestation or lactation.

No interventions assigned to this group

Interventions

Fish oil supplements

Women who chose to supplement with fish oil during gestation or lactation.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Deanna Gibson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna L Gibson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

References

Quin C, Estaki M, Vollman DM, Barnett JA, Gill SK, Gibson DL. Probiotic supplementation and associated infant gut microbiome and health: a cautionary retrospective clinical comparison. Sci Rep. 2018 May 29;8(1):8283. doi: 10.1038/s41598-018-26423-3.

Reference Type: DERIVED

PMID: 29844409 (View on PubMed)

Other Identifiers

H13-02523

Identifier Type: -

Identifier Source: org_study_id