Investigating the impact of gut microbiome and nutrition on pregnancy outcomes
Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy
This study is trying to see how a pregnant woman's diet and gut bacteria affect her baby's health and growth, focusing on younger moms in Toronto who might not be getting enough nutrition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | N/A to 28 Years |
| Sex | Female |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 2 sites (Toronto and 1 other locations) |
| Trial ID | NCT04992104 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how a mother's nutritional status and gut microbiome during pregnancy affect the health and birth outcomes of her baby. It focuses on pregnant women aged 28 years and younger in the Toronto area, particularly those vulnerable to undernutrition. Participants will provide stool samples, blood samples, and dietary assessments throughout their pregnancy and for a year after delivery. The study seeks to establish the relationship between maternal nutrition, microbiome dynamics, and newborn growth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 28 years and younger who are between 8-20 weeks post-conception.
Not a fit: Patients who are over 28 years old or more than 20 weeks post-conception will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional interventions for pregnant women, enhancing birth outcomes and infant health.
How similar studies have performed: While the specific focus on the microbiome and nutrition in this demographic is novel, related studies have shown promising results in understanding the microbiome's impact on health.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto and 1 other locations
- St. Michael's Hospital — Toronto, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: John Parkinson, PHD — The Hospital for Sick Children
- Study coordinator: Jessie Hulst, MD
- Email: jessie.hulst@sickkids.ca
- Phone: 416-813-7735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.