Microbiome and Malnutrition in Pregnancy

NCT04992104 | Active Not Recruiting

• 2 other identifiers: CTOREB3512MRT-168043
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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).

  8-20 weeks post-conception, 30-34 weeks post conception

Secondary Outcomes (54)

• Anthropometrics: Maternal BMI

  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

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

• Anthropometrics: Maternal triceps skinfold thickness

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

• Anthropometrics: Maternal height

  8-20 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum

• Anthropometrics: Maternal weight

  8-20 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum

Eligibility Criteria

• Age: Up to 28 Years
• Gender Eligibility Details: Biological sex: as the study's primary aim is to investigate pregnancy, participation will be restricted to participants who are biologically female. However, the study is inclusive with respect to gender, including both cis-gendered and trans-gendered participants (biological female-to-male).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Women who do not meet the enrolment age criteria
• Women who are 20 + weeks post-conception

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Unity Health Toronto: collaborator
• University of Toronto: collaborator
• University of Calgary: collaborator
• Dalhousie University: collaborator
• Aga Khan University: collaborator
• University of Alberta: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

St. Michael's Hospital

Toronto, Canada

Location

The Hospital for Sick Children

Toronto, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following samples will be collected: blood samples, stool samples and rectal swabs. Participants will have the option to have their blood samples biobanked for future genetic testing (This would be a separate study application in the future). More information on sample analysis can be found in section 10 of the protocol

MeSH Terms

Conditions

Pregnancy Complications; Parasitic Diseases; Communicable Diseases; Malnutrition; Infant Nutrition Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• John Parkinson, PHD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Shazeen Suleman, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 5, 2021
• Study Start: February 22, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All sequence and metabolomics data will be made available within 12 months of study completion Supporting information will be shared at time of request
• Access Criteria: Supporting information will be shared upon request Sequence and metabolomics datasets will be made available without restriction

Locations

CA (2)