Pregnancy RelatedMMIPNCT04992104
Microbiome and Malnutrition in Pregnancy
An observational study of Pregnancy Related and Pregnancy Loss, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 28 years, women only
- Conditions the study is for
- Pregnancy Related, Pregnancy Loss, Pregnancy Complications
- How many people
- 800 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Feb 2023to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 28 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of pregnant women, 28 years of age and younger, living in the Toronto and Greater Toronto Area. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition
Who may be able to join
- Consent provided
- Participant is between 8-20 weeks post-conception
- Female aged 28 years of age and younger
- Confirmation of pregnancy
- Intend to comply with study procedures and follow up
Who cannot join
- Women who do not meet the enrolment age criteria
- Women who are 20 + weeks post-conception
- Women who have taken antibiotics within the past 3 months Note: it is common practice to give the mother penicillin in perinatal period if they are GBS positive; because this is standardized across the board it would not act as an exclusion factor.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto
The Hospital for Sick Children
Toronto
About this study
Official title: Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy
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.
Read the detailed description
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.
- Conditions
- Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease, Microbial Colonization, Microbial Disease
- Medical subject headings
- Pregnancy Complications, Parasitic Diseases, Communicable Diseases, Malnutrition, Infant Nutrition Disorders, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
To 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).
Measured: 8-20 weeks post-conception, 30-34 weeks post conception
Secondary outcomes (54)
Anthropometrics: Maternal BMI
calculated using weight and height; BMI = kg/m2
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Infant sex
Female or Male
Measured: Determined at delivery
Infant morbidity
Assessed through infant health assessment questionnaires
Measured: 3 months, 6 months and 12 months
Maternal morbidity
Assessed through health assessment questionnaires
Measured: 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
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Measured in cm
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Measured in cm
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Measured in cm
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Measured in cm
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant Gestational age
Will be documented at baseline visit.
Measured: 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)
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Maternal age
28 years or younger
Measured: Documented at 8-20 weeks post-conception
Reported maternal medication use
[Questionnaire]
Measured: 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]
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 3 months post-partum and 12 months post partum
Preterm birth
noted in labor and birth chart review
Measured: Within 24 hours of birth
Stillbirth
noted in labor and birth chart review
Measured: Within 24 hours of birth
Small for gestational age
noted in labor and birth chart review
Measured: Within 24 hours of birth
Large for gestational age
noted in labor and birth chart review
Measured: Within 24 hours of birth
Birth size: length
Measured in cm
Measured: within 24 hours of birth
Birth size: head circumference
Measured in cm
Measured: within 24 hours of birth
Birth size: weight
Measured in kg
Measured: within 24 hours of birth
Birth defects
Assessed within 24 hours of birth
Measured: within 24 hours of birth
Delivery assessment
Assessed within 24 hours of birth
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months and 12 months
Maternal: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Infant: gut bacterial profile as measured through 16S rDNA sequence surveys
measured through 16S rDNA sequence surveys
Measured: 3 and 12 months post partum
Maternal metabolic pathway expression profile as measured through whole microbiome RNASeq (metatranscriptomics)
measured through whole microbiome RNASeq (metatranscriptomics)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start22 Feb 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, University of Toronto, University of Calgary, Dalhousie University, Aga Khan University, University of Alberta, National Institute of Allergy and Infectious Diseases (NIAID), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, John Parkinson, The Hospital for Sick Children
- Investigators
- John Parkinson, PHD, Principal investigator, The Hospital for Sick ChildrenShazeen Suleman, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992104
- Sponsor's protocol ID
- CTOREB3512
- Other IDs
- MRT-168043
- Acronym
- MMIP
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to publishing findings in open access journals, the investigators will ensure all sequences and metabolomics datasets are deposited in appropriate public repositories. SOPs, pathogen samples and statistical methods developed through this project will be shared with the IMPACTT research core (https://www.impactt-microbiome.ca/). Microbiome sequence data will be uploaded on the National Centre for Biotechnology Information (NCBI). The NCBI acts as a central data repository for sequence data. In line with publication standards, the investigators are required to provide access to users who may wish to follow up on analyzing the microbiome data for their own purposes. The sample analysis information, including the sequencing data and metabolomics data will be de-identified and the patient sequence data will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy
- ClinicalTrials.gov ID
- NCT04992104
- Acronym / sponsor ID
- MMIP / CTOREB3512
- Conditions
- Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease, Microbial Colonization, Microbial Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Unity Health Toronto, University of Toronto, University of Calgary, Dalhousie University, Aga Khan University, University of Alberta, National Institute of Allergy and Infectious Diseases (NIAID), Canadian Institutes of Health Research (CIHR)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Aug 2021 (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.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of pregnant women, 28 years of age and younger, living in the Toronto and Greater Toronto Area. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition
Key inclusion criteria (5 listed)
- Consent provided
- Participant is between 8-20 weeks post-conception
- Female aged 28 years of age and younger
- Confirmation of pregnancy
- Intend to comply with study procedures and follow up
Key exclusion criteria (3 listed)
- Women who do not meet the enrolment age criteria
- Women who are 20 + weeks post-conception
- Women who have taken antibiotics within the past 3 months Note: it is common practice to give the mother penicillin in perinatal period if they are GBS positive; because this is standardized across the board it would not act as an exclusion factor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are associated with changes in maternal gestational weight gain.
Time frame: 8-20 weeks post-conception, 30-34 weeks post conception
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).
54 secondary outcomes
Anthropometrics: Maternal BMI
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
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
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum
Anthropometrics: Maternal height
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
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
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Infant blood biomarkers
Time frame: 12 months
Infant sex
Time frame: Determined at delivery
Infant morbidity
Time frame: 3 months, 6 months and 12 months
Maternal morbidity
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
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant Gestational age
Time frame: 8-20 weeks post conception
Breast feeding: amount and initiation of complementary feeding
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Maternal age
Time frame: Documented at 8-20 weeks post-conception
Reported maternal medication use
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
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Maternal dietary intake
Time frame: 8-20 weeks post conception, 30-34 weeks post conception and 12 months post partum
Dietary diversity
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
Time frame: 3 months post-partum and 12 months post-partum
Self-efficacy
Time frame: 3 months post-partum and 12 months post partum
Perceived decision making
Time frame: 3 months post-partum and 12 months post partum
Perceived social support
Time frame: 3 months post-partum and 12 months post partum
Maternal demographics
Time frame: 8-20 weeks post-conception
Food insecurity
Time frame: 8-20 weeks post conception, 3 months post partum and 12 months post partum
Perceived parental stress
Time frame: 3 months post-partum and 12 months post partum
Preterm birth
Time frame: Within 24 hours of birth
Stillbirth
Time frame: Within 24 hours of birth
Small for gestational age
Time frame: Within 24 hours of birth
Large for gestational age
Time frame: Within 24 hours of birth
Birth size: length
Time frame: within 24 hours of birth
Birth size: head circumference
Time frame: within 24 hours of birth
Birth size: weight
Time frame: within 24 hours of birth
Birth defects
Time frame: within 24 hours of birth
Delivery assessment
Time frame: within 24 hours of birth
Infant dietary intake: NutricheQ Questionnaire
Time frame: 12 months
Maternal stool biomarkers: Calprotectin, Lipocalin and Claudin 15
Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. In addition to publishing findings in open access journals, the investigators will ensure all sequences and metabolomics datasets are deposited in appropriate public repositories. SOPs, pathogen samples and statistical methods developed through this project will be shared with the IMPACTT research core (https://www.impactt-microbiome.ca/). Microbiome sequence data will be uploaded on the National Centre for Biotechnology Information (NCBI). The NCBI acts as a central data repository for sequence data. In line with publication standards, the investigators are required to provide access to users who may wish to follow up on analyzing the microbiome data for their own purposes. The sample analysis information, including the sequencing data and metabolomics data will be de-identified and the patient sequence data will be removed.
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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.
John Parkinson, PHD principal investigator
The Hospital for Sick Children
Shazeen Suleman, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy Loss, run by The Hospital for Sick Children at 2 sites in Canada.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are associated with changes in maternal gestational weight gain. (time frame: 8-20 weeks post-conception, 30-34 weeks post conception). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.