The Alberta BLOOM Long Term Follow Up Study

Terminated

• Conditions: Infant, Premature, Diseases; Infant; Infant, Extremely Premature; Asthma; Allergies; Asthma in Children

• Registration Number: NCT04641000
• Lead Sponsor: University of Calgary

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study Start: 2020-11-20
• Study First Posted: 2020-11-23
• Primary Completion: 2021-08-16
• Status Verified: 2022-03
• Study Completion: 2022-03-26
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

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Exclusion Criteria

1. Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
2. Has major chromosomal anomalies.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Allergies	1-2 Years Corrected Gestational Age	Skin reactivity to common allergens as assessed by a skin prick test.
Asthma Risk	1-2 Years Corrected Gestational Age	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.
Microbiome Establishment and Assembly	1-2 Years Corrected Gestational Age	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.
Metabolome	1-2 Years Corrected Gestational Age	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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada