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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Maximum Age: 28
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Jessie Hulst, MD
jessie.hulst@sickkids.ca
416-813-7735
Backup
Gowshigga Thamotharampillai, MSc
gowshigga.thamotharampillai@sickkids.ca
437-991-7016
Time Frame
Start Date: 2023-02-22
Estimated Completion Date: 2027-03
Participants
Target number of participants: 800
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), National Institute of Allergy and Infectious Diseases (NIAID), Dalhousie University, Aga Khan University, University of Toronto, University of Alberta, University of Calgary, Unity Health Toronto
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov