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Clinical Trials in Canada / NCT04992104
Active, not recruiting Observational

Microbiome and Malnutrition in Pregnancy

NCT04992104 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2023-02-22
Last updated
2026-04-28

Condition(s) studied

Pregnancy RelatedPregnancy LossPregnancy ComplicationsPregnancy; Parasitic DiseaseMicrobial ColonizationMicrobial DiseaseParasitic DiseaseMetabolomicsMalnutritionMalnutrition, InfantMalnutrition PregnancyBreast Feeding

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.

Eligibility

Sex
FEMALE
Min age
—
Max age
28 Years
Healthy volunteers
No
Inclusion Criteria: 1. Consent provided 2. Participant is between 8-20 weeks post-conception 3. Female aged 28 years of age and younger 4. Confirmation of pregnancy 5. Intend to comply with study procedures and follow up Exclusion Criteria: 1. Women who do not meet the enrolment age criteria 2. Women who are 20 + weeks post-conception 3. 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
St. Michael's Hospital Toronto Canada
The Hospital for Sick Children Toronto Canada

More The Hospital for Sick Children trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04992104 on ClinicalTrials.gov ↗ ← All trials in Canada