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Microbiome, Atopic Disease, Prematurity (MAP)

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ClinicalTrials.gov Identifier: NCT04835935
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sydney Leibel, University of California, San Diego

Brief Summary:

There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies.

Our specific aims are:

  1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics.
  2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns.
  3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age.

The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.


Condition or disease Intervention/treatment
Atopy Prematurity Other: microbiome pattern

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association Between Milk Feedings in the Preterm Population, the Microbiome and Risk of Atopic Disease
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : June 30, 2025

Group/Cohort Intervention/treatment
subject who developed atopic disease Other: microbiome pattern
microbiome pattern in neonatal period

subject who did not develop atopic disease Other: microbiome pattern
microbiome pattern in neonatal period




Primary Outcome Measures :
  1. Pediatric Atopic Disease [ Time Frame: 2-3 years of age ]
    Clinical diagnosis of any atopic disease among the participants during study follow up visit. These include any food allergies, allergic rhinitis, eczema, and asthma.


Secondary Outcome Measures :
  1. Allergic sensitization patterns [ Time Frame: 1-2 years ]
    Allergic sensitization patterns among the participants will be measured by ImmunoCAP Multitest, which is a blood test that provides qualitative responses (positive or negative) for food and environmental allergens.


Other Outcome Measures:
  1. Gut, oral and milk feed microbiome [ Time Frame: birth to 1 year of age ]
    Longitudinal stool, oral swab and milk feed samples will be analyzed for paired microbiome and metabolome patterns. The bacterial and metabolomic profiles will be correlated with the allergic sensitization patterns and diagnosis of pediatric atopic disease in participants.


Biospecimen Retention:   Samples With DNA
Stool, breast milk, saliva


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants born at equal or less than 34 weeks gestational age.
Criteria

Inclusion Criteria:

  • premature infant equal or less than 34 weeks of age

Exclusion Criteria:

  • hypoxic ischemic encephalopathy, congenital anomaly that affects gastrointestinal system, unable to follow up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835935


Locations
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United States, California
Scripps Memorial Hospital - Rady NICU
San Diego, California, United States, 92037
University of California, San Diego - Jacobs NICU
San Diego, California, United States, 92093
Sponsors and Collaborators
Sydney Leibel
Publications:

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Responsible Party: Sydney Leibel, Assoc Physician, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04835935    
Other Study ID Numbers: 181711
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: de-identified microbiome and metabolome data will be available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications