University of Calgary
Calgary, Alberta, T2N 2T9, Canada
NCT Number: NCT05011071
This is a prospective, observational clinical cohort study involving 405 children born premature (at less than 37 weeks gestation) and their mother/parent/guardian. The purpose of the study is to investigate how the microbiome (the collection of microbes in a biological site) of children develops over the first years of life and its associations with the risk of childhood health outcomes including allergies and asthma. The study will also examine how perinatal factors associate with patterns of microbiome development, and their effects on the microbiome, metabolome (the collection of metabolites in a biological sample) and immune development of this population in the first years of life.
Interested in participating?
Request Info0 day and older
All sexes
Observational
Calgary, Alberta, T2N 2T9, Canada
Premature birth (birth before 37 weeks of pregnancy) occurs in about 1 in 10 pregnancies. When infants are born prematurely their gut is not as developed. One important factor in gut health is the large community of microbes (tiny living things such as bacteria) that live on the human body called the microbiome. Recent studies have shown that premature infants are more likely to experience changes to their gut microbiome that are associated with health issues, such as asthma and allergies. However, the specific microbiome features of children born preterm and the role of their microbiome in disease risk and childhood health is not well understood. The Alberta BLOOM Premature Child Study (PCS) investigates how the microbiome and immune health of premature children develops over the first years of life and its associations with the risk of childhood health outcomes. BLOOM-PCS will also study how the microbiome of children born premature differs from the microbiome in the term population.
The type of microbes that are present in the infant's gut in the first months of life have a major impact on the microbiome that will form during childhood. There are many environmental factors during pregnancy, birth and the first months of life that can impact an infant's microbiome development. Factors such as diet, exposure to antibiotics, surgical procedures, and mode of delivery can strongly affect early microbiome development. This study will investigate how these factors influence the types of early microbes present in preterm infants.
This study hypothesizes that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/on infant factors. Also, that microbial alterations resulting from preterm birth contributes to the allergy and asthma outcomes in infants through immune mechanisms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Child Inclusion Criteria:
Mother/Parent/Legal Guardian Inclusion Criteria:
Exclusion criteria
Child Exclusion Criteria:
Mother/Parent/Legal Guardian Exclusion Criteria:
Time frame: 1-3.5 Years Corrected Gestational Age
Infant outcomes as assessed by the Asthma Predictive Index, a validated methodology that helps predict asthma in young children by determining history of wheeze, atopic dermatitis, familial history and eosinophilia, and skin reactivity to common allergens via a skin prick test.
Time frame: 0-3.5 Years Corrected Gestational Age
Microbiome establishment, fecal microbial diversity and the relative abundance of bacterial and eukaryotic taxa, as assessed by sequencing of the 16S and ITS2 gene and functional analysis via shotgun metagenomatic sequencing.
Time frame: 0-3.5 Years Corrected Gestational Age
Human and microbial metabolites as assessed by untargeted metabolomics, ultra-performance liquid chromatography ultrahigh-resolution Fournier transform (FT) combined with mass spectrometry.
Time frame: 0-3.5 Years Corrected Gestational Age
Influence of perinatal factors (environment, nutrition, pharmacological exposure) on the microbiome, metabolome and immunobiome; association between perinatal factors, preterm delivery, and the patterns of microbiome, metabolome and immunobiome development.
University of Calgary
Other
The Alberta BLOOM Premature Child Study: Impact of the Microbiome on the Clinical Course and Health Outcomes of Premature Children
Acronym: BLOOM-PCS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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