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Active, Not Recruiting

NCT Number: NCT04992104

Microbiome and Malnutrition in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    calculated using weight and height; BMI = kg/m2

  2. 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

    Measured in cm

  3. 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

    Measured in cm

  4. 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

    Measured in cm

  5. 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

    Measured in kg

  6. Maternal blood biomarkers

    Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum

    Concentration of HB + MCV, ferritin, and CRP

  7. Infant blood biomarkers

    Time frame: 12 months

    Concentration of HB + MCV, ferritin, and CRP

  8. Infant sex

    Time frame: Determined at delivery

    Female or Male

  9. Infant morbidity

    Time frame: 3 months, 6 months and 12 months

    Assessed through infant health assessment questionnaires

  10. 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

    Assessed through health assessment questionnaires

  11. Infant growth: weight

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Measured in kg

  12. Infant growth: length

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Measured in cm

  13. Infant growth: head circumference

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Measured in cm

  14. Infant growth: mid upper arm circumference

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Measured in cm

  15. Infant growth: triceps skinfold thickness

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Measured in cm

  16. Infant Gestational age

    Time frame: 8-20 weeks post conception

    Will be documented at baseline visit.

  17. Breast feeding: amount and initiation of complementary feeding

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    Based off of WHO 2010 Guidelines: Indicators for assessing infant and young child feeding practices (Part 2 Measurement)

  18. Maternal age

    Time frame: Documented at 8-20 weeks post-conception

    28 years or younger

  19. 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

    [Questionnaire]

  20. Reported Infant medication use

    Time frame: within 24 hours of birth, 3 months, 6 months and 12 months

    [Questionnaire]

  21. Maternal dietary intake

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception and 12 months post partum

    Assessed through ASA 24 HR Dietary Recall system, completed 2x each time point

  22. Dietary diversity

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post-partum and 12 months post partum

    Minimum Dietary Diversity Score for Women (MDD-W)

  23. Household annual food insecurity

    Time frame: 3 months post-partum and 12 months post-partum

    Food insecurity will be assessed using the Household Food Insecurity Access Scale (HFIAS)

  24. Self-efficacy

    Time frame: 3 months post-partum and 12 months post partum

    Self-efficacy will be measured using the Generalized Self-Efficacy scale, developed by Schwarzer and Jerusalem

  25. Perceived decision making

    Time frame: 3 months post-partum and 12 months post partum

    Questions pertaining to perceived decision-making are from the Pakistan Demographic and Health Survey (PDHS)

  26. Perceived social support

    Time frame: 3 months post-partum and 12 months post partum

    Perceived social support will be measured using the Multi-dimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al.

  27. Maternal demographics

    Time frame: 8-20 weeks post-conception

    Questions pertaining to demographic data are adapted from the Pakistan Demographic and Health Survey (PDHS)

  28. Food insecurity

    Time frame: 8-20 weeks post conception, 3 months post partum and 12 months post partum

    Questionnaire developed by Hager, E.R., et al., Development and validity of a 2-item screen to identify families at risk for food insecurity.

  29. Perceived parental stress

    Time frame: 3 months post-partum and 12 months post partum

    Perceived parental stress will be measured using the Perceived Stress Scale (PSS-10)

  30. Preterm birth

    Time frame: Within 24 hours of birth

    noted in labor and birth chart review

  31. Stillbirth

    Time frame: Within 24 hours of birth

    noted in labor and birth chart review

  32. Small for gestational age

    Time frame: Within 24 hours of birth

    noted in labor and birth chart review

  33. Large for gestational age

    Time frame: Within 24 hours of birth

    noted in labor and birth chart review

  34. Birth size: length

    Time frame: within 24 hours of birth

    Measured in cm

  35. Birth size: head circumference

    Time frame: within 24 hours of birth

    Measured in cm

  36. Birth size: weight

    Time frame: within 24 hours of birth

    Measured in kg

  37. Birth defects

    Time frame: within 24 hours of birth

    Assessed within 24 hours of birth

  38. Delivery assessment

    Time frame: within 24 hours of birth

    Assessed within 24 hours of birth

  39. Infant dietary intake: NutricheQ Questionnaire

    Time frame: 12 months

    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

  40. 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

    Markers in the stool for intestinal mass, inflammation, and gut permeability and circulating lipopolysaccharide, among other markers

  41. Infant Stool biomarkers: Calprotectin, Lipocalin and Claudin 15

    Time frame: 3 months and 12 months

    Markers in the stool for intestinal mass, inflammation, and gut permeability and circulating lipopolysaccharide, among other markers

  42. Maternal: incidence of pathobionts

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum

    As identified through 16S, 18S and ITS rDNA surveys

  43. Infant: incidence of pathobionts

    Time frame: 3 months and 12 months

    As identified through 16S, 18S and ITS rDNA surveys

  44. Maternal: metabolomic profile of stool (metabolites involved in central metabolism as analysed by Mass Spectrometry)

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum

    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

  45. Maternal gut bacteria profile as 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

    measured through 16S rDNA sequence surveys

  46. Maternal: blood metallomics profile as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25)

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception, and 12 months post partum

    TMIC Metallomics Platform to be used.

  47. Infant: blood metallomics profile as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25)

    Time frame: 12 months

    Through TMIC platform

  48. Infant: gut bacterial profile as measured through 16S rDNA sequence surveys

    Time frame: 3 and 12 months post partum

    measured through 16S rDNA sequence surveys

  49. Maternal metabolic pathway expression profile as 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

    measured through whole microbiome RNASeq (metatranscriptomics)

  50. Infant eukaryotic microbiome profile as measured through 18S and ITS rDNA sequence surveys

    Time frame: 3 months and 12 months

    measured through 18S and ITS rDNA sequence surveys

  51. Maternal eukaryotic microbiome profile as 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

    measured through 18S and ITS rDNA sequence surveys

  52. Maternal bacterial gene expression profile as 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

    The output of these analyses are readouts of microbial gene expression detailing biochemical activities as well as the taxa responsible.

  53. Maternal: microbiome taxonomic alpha and beta diversity

    Time frame: 8-20 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum

    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.

  54. Infant: microbiome taxonomic alpha and beta diversity

    Time frame: 3 months and 12 months

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Aga Khan University
  • Canadian Institutes of Health Research (CIHR)
  • Dalhousie University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Unity Health Toronto
  • University of Alberta
  • University of Calgary
  • University of Toronto

Registry information

Official study title

Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy

Acronym: MMIP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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