Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2023-02-22
2027-03-31
Brief Summary
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Detailed Description
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At the core of this study are two complementary cohorts of young women that provide an exceptional opportunity to obtain longitudinal samples to monitor the dynamic relationships between microbiome community structure and function with gut health and host nutritional status. This registration is for the the Toronto cohort of the study, which will focus on refugee and young adult obstetric clinics in Toronto, a population of specific relevance to undernutrition. This cohort is expected to yield insights into the influence of eukaryotic microbes that are often viewed as asymptomatic. The target demographic of the study is young mothers, 28 years of age and younger, in the Toronto and Greater Toronto Area. The investigators have identified this younger demographic due to the lack of knowledge on the microbiome of young women, and their vulnerability to undernutrition. A second complementary cohort will be based in the Matiari district of Pakistan. This project will yield unprecedented insights into the relationships between prokaryotic and eukaryotic microbes in the gut and their associations with maternal health and birth outcomes.
The central hypothesis of the study is 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.
The study will be a prospective, longitudinal, observational study to investigate the impact and relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal health and birth outcomes among young women, 28 years of age and younger in the Toronto and Greater Toronto Area. The study will aim to recruit 400 women into two groups based on BMI at time of recruitment (Normal BMI will be defined as between 20 and 24.9 kg/m2 and Low BMI will be defined as less than 20 kg/m2). With a goal of having 200 participants within the normal BMI group and 200 participants within the low BMI group. Although this is the recruitment aim, in the event that the investigators are unable to recruit 200 women with a low BMI, more women will be recruited that fall within the normal BMI range. The study will follow women and their infants over the course of their pregnancy and for a year post-partum, collecting stool, rectal and blood samples, nutritional information, heath assessments, anthropometric measurements and empowerment metrics at different time points.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
28 Years
FEMALE
No
Sponsors
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Unity Health Toronto
OTHER
University of Toronto
OTHER
University of Calgary
OTHER
Dalhousie University
OTHER
Aga Khan University
OTHER
University of Alberta
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Hospital for Sick Children
OTHER
Responsible Party
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John Parkinson
Senior Scientist
Principal Investigators
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John Parkinson, PHD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Shazeen Suleman, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, , Canada
The Hospital for Sick Children
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Shazeen Suleman, MD
Role: primary
John Parkinson, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MRT-168043
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CTOREB3512
Identifier Type: -
Identifier Source: org_study_id