Microbiome and Malnutrition in Pregnancy

NCT04992104 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-04-28

No results posted yet for this study

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. 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.

Conditions

  • Pregnancy Related
  • Pregnancy Loss
  • Pregnancy Complications
  • Pregnancy; Parasitic Disease
  • Microbial Colonization
  • Microbial Disease
  • Parasitic Disease
  • Metabolomics
  • Malnutrition
  • Malnutrition, Infant
  • Malnutrition Pregnancy
  • Breast Feeding

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • University of Calgary

    collaborator OTHER
  • Dalhousie University

    collaborator OTHER
  • Aga Khan University

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • John Parkinson, PHD · The Hospital for Sick Children

  • Shazeen Suleman, MD · Unity Health Toronto

Eligibility

Max Age
28 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992104 on ClinicalTrials.gov