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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04641000
Other study ID # REB19-1780
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 20, 2020
Est. completion date March 26, 2022

Study information

Verified date March 2022
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation. The purpose of this study is to investigate the microbiome (the collection of microbes in a biological site) alternations resulting from preterm birth and associations with the risk of immune dysregulation, asthma and allergies.


Description:

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 babies are more likely to have changes in their gut microbiome that are associated with health issues. However, the specific microbiome features that are involved in the development of premature babies is still unknown. Therefore, this study examines the impact of very premature birth on the baby's microbiome, and how microbiome alterations are involved in health issues such as immune dysregulation, allergies and asthma. The large communities of microbes in the gut play a major role on the microbiome that will form during infancy and childhood. Factors such as diet, exposure to antibiotics, surgical procedures, and mode of delivery, can strongly affect the dynamics microbiome development. It is well known that microbiome alterations are associated with disorders such as asthma. However, the features involved in disease development and progression are highly understudied. Through this clinical study, we will evaluate associations between the early patterns of microbial colonization in premature infants and their risk to develop asthma later in childhood. The hypothesis of the study is that microbial alterations resulting from preterm birth causally contribute to the allergy and asthma risk in infants (defined by atopic-wheeze) through immune mechanisms.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date March 26, 2022
Est. primary completion date August 16, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 2 Years
Eligibility Inclusion Criteria: 1. Born at = 31 weeks + 6 days gestation (316/7 weeks); 2. Previously participated in the PROBIO and/or BLOOM PTN and/or BLOOM PTB research studies. 3. Provide a signed and dated informed consent form. 4. Willing and able to attend a clinic visit at Alberta Children's Hospital in Calgary, Alberta. 5. Parent/guardian providing consent must be able to speak and understand English. Exclusion Criteria: 1. Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery. 2. Has major chromosomal anomalies.

Study Design


Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Calgary Canadian Institutes of Health Research (CIHR), University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiome Establishment and Assembly Fecal microbial diversity and the relative abundance of bacterial and eukaryotic taxa, as assessed by polymerase chain reaction of the 16S and ITS2 gene and functional analysis on 16S taxonomic surveys for all participants from birth to around 1-year CGA. Changes in fecal microbial diversity and microbial population structures from birth to around 1-year CGA for all participants as assessed by shotgun metagenomics. 1-2 Years Corrected Gestational Age
Primary Metabolome Human and microbial metabolites as assessed by untargeted metabolomics, ultra-performance liquid chromatography ultrahigh-resolution Fourier transform (FT) combined with mass spectrometry to identify human and microbial metabolites for all participants from birth to around 1-year CGA. 1-2 Years Corrected Gestational Age
Primary Asthma Risk Health outcomes such as asthma risk that are influenced by novel linkages between gut microbiome features (taxonomical and functional) as assessed by the Asthma Predictive Index, which involves determining history of wheeze, atopic dermatitis, familial history and eosinophilia. 1-2 Years Corrected Gestational Age
Primary Allergies Skin reactivity to common allergens as assessed by a skin prick test. 1-2 Years Corrected Gestational Age
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