Infant, Premature, DiseasesBLOOM-LTFUNCT04641000
The Alberta BLOOM Long Term Follow Up Study
An observational study of Infant, Premature, Diseases and Infant, run by University of Calgary at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Infant, Premature, Diseases, Infant, Asthma
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2020to 26 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Born at ≤ 31 weeks + 6 days gestation (316/7 weeks);
- Previously participated in the PROBIO and/or BLOOM PTN and/or BLOOM PTB research studies.
- Provide a signed and dated informed consent form.
- Willing and able to attend a clinic visit at Alberta Children's Hospital in Calgary, Alberta.
- Parent/guardian providing consent must be able to speak and understand English.
Who cannot join
- Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
- Has major chromosomal anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children, Allergies, Infant, Extremely Premature
- Keywords
- Microbiota, Microbiome, Gastrointestinal Microbiome
- Medical subject headings
- Infant, Premature, Diseases, Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-2 Years Corrected Gestational Age
Allergies
Skin reactivity to common allergens as assessed by a skin prick test.
Measured: 1-2 Years Corrected Gestational Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start20 Nov 2020
- Primary completion16 Aug 2021
- Study completion26 Mar 2022
Why it stopped: The BLOOM-LTFU study has evolved into the ongoing BLOOM-PCS Study (REB20-1442).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marie-Claire Arrieta, University of Calgary
- Investigators
- Marie-Claire Arrieta, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641000
- Sponsor's protocol ID
- REB19-1780
- Acronym
- BLOOM-LTFU
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asbury MR, Guedez A, Lee J, Mercer EM, Kasaba F, Rangipour Z, Kellner JD, Lacaze-Masmonteil T, Samara J, Leijser LM, Lebel C, Zein H, Hendson L, Murguia Favela L, McNagny K, Giesbrecht GF, Sycuro L, Alshaikh B, Arrieta MC. Exploring the Early-Life Microbiomes of Preterm Infants and Their Childhood Health Outcomes (The BLOOM Study): Protocol for a Prospective, Observational Cohort Study. JMIR Res Protoc. 2026 Aug 18;15:e95658. doi: 10.2196/95658.
PubMed 42612036
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alberta BLOOM Long Term Follow Up Study: The Microbiome of Preterm Children in Immune Development
- ClinicalTrials.gov ID
- NCT04641000
- Acronym / sponsor ID
- BLOOM-LTFU / REB19-1780
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children, Allergies, Infant, Extremely Premature
- Keywords
- Microbiota, Microbiome, Gastrointestinal Microbiome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The BLOOM-LTFU study has evolved into the ongoing BLOOM-PCS Study (REB20-1442).
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- Born at ≤ 31 weeks + 6 days gestation (316/7 weeks);
- Previously participated in the PROBIO and/or BLOOM PTN and/or BLOOM PTB research studies.
- Provide a signed and dated informed consent form.
- Willing and able to attend a clinic visit at Alberta Children's Hospital in Calgary, Alberta.
- Parent/guardian providing consent must be able to speak and understand English.
Key exclusion criteria (2 listed)
- Has congenital gastrointestinal anomalies or has a history of gastrointestinal surgery.
- Has major chromosomal anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome Establishment and Assembly
Time frame: 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
Time frame: 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.
Asthma Risk
Time frame: 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.
Allergies
Time frame: 1-2 Years Corrected Gestational Age
Skin reactivity to common allergens as assessed by a skin prick test.
Results and safety
The study was stopped early (reason given: The BLOOM-LTFU study has evolved into the ongoing BLOOM-PCS Study (REB20-1442).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 42612036Asbury MR, Guedez A, Lee J, Mercer EM, Kasaba F, Rangipour Z, Kellner JD, Lacaze-Masmonteil T, Samara J, Leijser LM, Lebel C, Zein H, Hendson L, Murguia Favela L, McNagny K, Giesbrecht GF, Sycuro L, Alshaikh B, Arrieta MC. Exploring the Early-Life Microbiomes of Preterm Infants and Their Childhood Health Outcomes (The BLOOM Study): Protocol for a Prospective, Observational Cohort Study. JMIR Res Protoc. 2026 Aug 18;15:e95658. doi: 10.2196/95658.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claire Arrieta, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Infant, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The BLOOM-LTFU study has evolved into the ongoing BLOOM-PCS Study (REB20-1442).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Establishment and Assembly (time frame: 1-2 Years Corrected Gestational Age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.