The Alberta BLOOM Long Term Follow Up Study (BLOOM-LTFU)

The Alberta BLOOM Long Term Follow Up Study: The Microbiome of Preterm Children in Immune Development

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.

Study Overview

• Status: Terminated
• Conditions: Infant, Premature, Diseases; Asthma; Asthma in Children; Infant; Infant, Extremely Premature; 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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study recruits very early preterm infants that previously participated on at least one of the PROBIO, BLOOM PTN or BLOOM PTB studies.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Allergies	Skin reactivity to common allergens as assessed by a skin prick test.	1-2 Years Corrected Gestational Age

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): March 26, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Microbiome; Microbiota; Gastrointestinal Microbiome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Asthma; Premature Birth
• Other Study ID Numbers: REB19-1780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No