Microbial ColonizationNCT03297801
The Effects of Omega-3 PUFAs on the Infant Microbiome and Immunity
An observational study of Microbial Colonization and Infant Development, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Infant Development
- What is being tested?
- Fish oil supplements
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy women in the Okanagan Valley who predominantly breastfeed their healthy, full-term infants while self-administering fish oil supplements or not.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Effects of Omega-3 Polyunsaturated Fatty Acids on the Infant Microbiome and Immunity
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.
Read the 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
- Being tested
- Fish oil supplements
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil supplementsDietary supplement
Women who chose to supplement with fish oil during gestation or lactation.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil group | Women who chose to supplement with fish oil, rich in omega-3 polyunsaturated fatty acids, during gestation or lactation. Receives: Dietary Supplement: Fish oil supplements | |
| No fish oil group | Women who chose not to supplement with fish oil during gestation or lactation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in infant fecal microbiota of the two groups.
Fecal microbiota will be measured by examining microbial taxa from infant stool every month from birth until 6-months of age or until solids are introduced.
Measured: 6 months
Secondary outcomes (7)
Changes in infant short-chain fatty acid production of the two groups.
Changes in short-chain fatty acid production will be analyzed in infant stool through gas chromatography.
Measured: 6 months
Changes in infant IgA in shed intestinal epithelial cells of the two groups.
We will examine the effects of fish oil on immunity by measuring fecal IgA concentrations using ELISA
Measured: 6 months
Changes in infant cytokines in shed intestinal epithelial cells of the two groups.
We will examine the effects of fish oil on immunity by measuring fecal cytokines (TNF-a, IFN-y, IL-17) using real time PCR.
Measured: 6 months
Compare occurrences of sickness and incidences of disease between the two groups.
Any incidences of disease in the infants will be closely monitored for the first 2 years of their lives.
Measured: 2 years
Changes in breast milk IgA composition of the two groups.
Immune markers such as sIgA will be measured in breast milk using an addressable laser bead immunoassay (ALBIA)
Measured: 6 months
Changes in breast milk cytokine composition of the two groups.
Immune markers such cytokines will be measured in breast milk using an addressable laser bead immunoassay (ALBIA)
Measured: 6 months
Changes in breast milk lipid composition of the two groups.
Breast milk lipid concentrations will be analyzed using short-chain fatty acids
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start22 Jan 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanna Gibson, University of British Columbia
- Investigators
- Deanna L Gibson, Ph.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297801
- Sponsor's protocol ID
- H13-02523
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Infant stool microbial data will be made open access upon publishing.
Publications
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.
PubMed 29844409
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Omega-3 Polyunsaturated Fatty Acids on the Infant Microbiome and Immunity
- ClinicalTrials.gov ID
- NCT03297801
- Acronym / sponsor ID
- H13-02523
- Conditions
- Microbial Colonization, Infant Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 22 Jan 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil group | – | Dietary Supplement: Fish oil supplementsWomen who chose to supplement with fish oil, rich in omega-3 polyunsaturated fatty acids, during gestation or lactation. |
| No fish oil group | – | –Women who chose not to supplement with fish oil during gestation or lactation. |
Who may qualify
- Ages
- 5 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy women in the Okanagan Valley who predominantly breastfeed their healthy, full-term infants while self-administering fish oil supplements or not.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil supplementsWomen who chose to supplement with fish oil during gestation or lactation. | Dietary supplement | Fish oil group |
Primary outcome
Changes in infant fecal microbiota of the two groups.
Time frame: 6 months
Fecal microbiota will be measured by examining microbial taxa from infant stool every month from birth until 6-months of age or until solids are introduced.
7 secondary outcomes
Changes in infant short-chain fatty acid production of the two groups.
Time frame: 6 months
Changes in infant IgA in shed intestinal epithelial cells of the two groups.
Time frame: 6 months
Changes in infant cytokines in shed intestinal epithelial cells of the two groups.
Time frame: 6 months
Compare occurrences of sickness and incidences of disease between the two groups.
Time frame: 2 years
Changes in breast milk IgA composition of the two groups.
Time frame: 6 months
Changes in breast milk cytokine composition of the two groups.
Time frame: 6 months
Changes in breast milk lipid composition of the two groups.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 29844409Quin 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.
- Individual participant dataSharing planned: No. Infant stool microbial data will be made open access upon publishing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna L Gibson, Ph.D. principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Infant Development, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in infant fecal microbiota of the two groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.