This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on pregnant women, 28 years and younger living in the Toronto and greater Toronto area. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. With the hypothesis that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.
This project represents the first systematic investigation of the impact of the microbiome on nutritional status during pregnancy in young women and directly aligns with global health initiatives focused on this vulnerable cohort. The goal of the study is to define the relationships between host nutritional status and microbiome dynamics during pregnancy and how they contribute to birth outcomes. The gut microbiome has a profound influence on host nutritional status. Dysbiosis (loss of diversity/beneficial microbes and gain of pathobionts) has emerged as a major factor in the development of undernutrition. Despite the importance of nutrition during pregnancy, few studies have examined the role of the microbiome on maternal health and birth outcomes. Further, little is known concerning the influence of enteric eukaryotic microbes, such as parasites, on the bacterial microbiome and host nutrition. At the core of this study are two complementary cohorts of young women that provide an exceptional opportunity to obtain longitudinal samples to monitor the dynamic relationships between microbiome community structure and function with gut health and host nutritional status. This registration is for the the Toronto cohort of the study, which will focus on refugee and young adult obstetric clinics in Toronto, a population of specific relevance to undernutrition. This cohort is expected to yield insights into the influence of eukaryotic microbes that are often viewed as asymptomatic. The target demographic of the study is young mothers, 28 years of age and younger, in the Toronto and Greater Toronto Area. The investigators have identified this younger demographic due to the lack of knowledge on the microbiome of young women, and their vulnerability to undernutrition. A second complementary cohort will be based in the Matiari district of Pakistan. This project will yield unprecedented insights into the relationships between prokaryotic and eukaryotic microbes in the gut and their associations with maternal health and birth outcomes. The central hypothesis of the study is that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes. The study will be a prospective, longitudinal, observational study to investigate the impact and relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal health and birth outcomes among young women, 28 years of age and younger in the Toronto and Greater Toronto Area. The study will aim to recruit 400 women into two groups based on BMI at time of recruitment (Normal BMI will be defined as between 20 and 24.9 kg/m2 and Low BMI will be defined as less than 20 kg/m2). With a goal of having 200 participants within the normal BMI group and 200 participants within the low BMI group. Although this is the recruitment aim, in the event that the investigators are unable to recruit 200 women with a low BMI, more women will be recruited that fall within the normal BMI range. The study will follow women and their infants over the course of their pregnancy and for a year post-partum, collecting stool, rectal and blood samples, nutritional information, heath assessments, anthropometric measurements and empowerment metrics at different time points.
Study Type
OBSERVATIONAL
Enrollment
800
St. Michael's Hospital
Toronto, Canada
RECRUITINGThe Hospital for Sick Children
Toronto, Canada
RECRUITINGTo assess if alterations of the microbiota in the maternal gut (dysbiosis) are associated with changes in maternal gestational weight gain.
The primary endpoint will be the change in maternal gestational weight gain (GWG) during pregnancy, measured between the first (8-20 weeks post-conception) and second time point (30-34 weeks post conception).
Time frame: 8-20 weeks post-conception, 30-34 weeks post conception
Anthropometrics: Maternal BMI
calculated using weight and height; BMI = kg/m2
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum
Anthropometrics: Maternal middle upper arm circumference
Measured in cm
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum,and 12 months post-partum
Anthropometrics: Maternal triceps skinfold thickness
Measured in cm
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum
Anthropometrics: Maternal height
Measured in cm
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum
Anthropometrics: Maternal weight
Measured in kg
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum
Maternal blood biomarkers
Concentration of HB + MCV, ferritin, and CRP
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Infant blood biomarkers
Concentration of HB + MCV, ferritin, and CRP
Time frame: 12 months
Infant sex
Female or Male
Time frame: Determined at delivery
Infant morbidity
Assessed through infant health assessment questionnaires
Time frame: 3 months, 6 months and 12 months
Maternal morbidity
Assessed through health assessment questionnaires
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, 3 months post-partum, 6 months post-partum and 12 months post-partum
Infant growth: weight
Measured in kg
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Measured in cm
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Measured in cm
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Measured in cm
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Measured in cm
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant Gestational age
Will be documented at baseline visit.
Time frame: 8-20 weeks post conception
Breast feeding: amount and initiation of complementary feeding
Based off of WHO 2010 Guidelines: Indicators for assessing infant and young child feeding practices (Part 2 Measurement)
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Maternal age
24 years or younger
Time frame: Documented at 8-20 weeks post-conception
Reported maternal medication use
\[Questionnaire\]
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, within 24 hours of delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum
Reported Infant medication use
\[Questionnaire\]
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Maternal dietary intake
Assessed through ASA 24 HR Dietary Recall system, completed 2x each time point
Time frame: 8-20 weeks post conception, 30-34 weeks post conception and 12 months post partum
Dietary diversity
Minimum Dietary Diversity Score for Women (MDD-W)
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post-partum and 12 months post partum
Household annual food insecurity
Food insecurity will be assessed using the Household Food Insecurity Access Scale (HFIAS)
Time frame: 3 months post-partum and 12 months post-partum
Self-efficacy
Self-efficacy will be measured using the Generalized Self-Efficacy scale, developed by Schwarzer and Jerusalem
Time frame: 3 months post-partum and 12 months post partum
Perceived decision making
Questions pertaining to perceived decision-making are from the Pakistan Demographic and Health Survey (PDHS)
Time frame: 3 months post-partum and 12 months post partum
Perceived social support
Perceived social support will be measured using the Multi-dimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al.
Time frame: 3 months post-partum and 12 months post partum
Maternal demographics
Questions pertaining to demographic data are adapted from the Pakistan Demographic and Health Survey (PDHS)
Time frame: 8-20 weeks post-conception
Food insecurity
Questionnaire developed by Hager, E.R., et al., Development and validity of a 2-item screen to identify families at risk for food insecurity.
Time frame: 8-20 weeks post conception, 3 months post partum and 12 months post partum
Perceived parental stress
Perceived parental stress will be measured using the Perceived Stress Scale (PSS-10)
Time frame: 3 months post-partum and 12 months post partum
Preterm birth
noted in labor and birth chart review
Time frame: Within 24 hours of birth
Stillbirth
noted in labor and birth chart review
Time frame: Within 24 hours of birth
Small for gestational age
noted in labor and birth chart review
Time frame: Within 24 hours of birth
Large for gestational age
noted in labor and birth chart review
Time frame: Within 24 hours of birth
Birth size: length
Measured in cm
Time frame: within 24 hours of birth
Birth size: head circumference
Measured in cm
Time frame: within 24 hours of birth
Birth size: weight
Measured in kg
Time frame: within 24 hours of birth
Birth defects
Assessed within 24 hours of birth
Time frame: within 24 hours of birth
Delivery assessment
Assessed within 24 hours of birth
Time frame: within 24 hours of birth
Infant dietary intake: NutricheQ Questionnaire
NutricheQ questionnaire: a tool designed for toddlers aged 1 to 3 years of age, with a focus on markers for inadequate or excessive intake and dietary imbalances
Time frame: 12 months
Maternal stool biomarkers: Calprotectin, Lipocalin and Claudin 15
Markers in the stool for intestinal mass, inflammation, and gut permeability and circulating lipopolysaccharide, among other markers
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant Stool biomarkers: Calprotectin, Lipocalin and Claudin 15
Markers in the stool for intestinal mass, inflammation, and gut permeability and circulating lipopolysaccharide, among other markers
Time frame: 3 months and 12 months
Maternal: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Time frame: 3 months and 12 months
Maternal: metabolomic profile of stool (metabolites involved in central metabolism as analysed by Mass Spectrometry)
Analysis of the core metabolites involved in central metabolism. These metabolites will be analysed through Mass Spec and include short chain fatty acids, amino acids, intermediates in energy metabolism and nucleotide biosynthesis
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal gut bacteria profile as measured through 16S rDNA sequence surveys
measured through 16S rDNA sequence surveys
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal: blood metallomics profile as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25)
TMIC Metallomics Platform to be used.
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, and 12 months post partum
Infant: blood metallomics profile as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25)
Through TMIC platform
Time frame: 12 months
Infant: gut bacterial profile as measured through 16S rDNA sequence surveys
measured through 16S rDNA sequence surveys
Time frame: 3 and 12 months post partum
Maternal metabolic pathway expression profile as measured through whole microbiome RNASeq (metatranscriptomics)
measured through whole microbiome RNASeq (metatranscriptomics)
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant eukaryotic microbiome profile as measured through 18S and ITS rDNA sequence surveys
measured through 18S and ITS rDNA sequence surveys
Time frame: 3 months and 12 months
Maternal eukaryotic microbiome profile as measured through 18S and ITS rDNA sequence surveys
measured through 18S and ITS rDNA sequence surveys
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal bacterial gene expression profile as measured through whole microbiome RNASeq (metatranscriptomics)
The output of these analyses are readouts of microbial gene expression detailing biochemical activities as well as the taxa responsible.
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Time frame: 3 months and 12 months
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