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Clinical Trials/NCT04835935
NCT04835935Active, not recruitingNot Applicable

The Association Between Milk Feedings in the Preterm Population, the Microbiome and Risk of Atopic Disease

Sydney Leibel2 sites in 1 country51 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
51
Locations
2
Primary Endpoint
Pediatric Atopic Disease

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Days to 7 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Allergic sensitization patterns(1-2 years)

Investigators

Sponsor
Sydney Leibel
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sydney Leibel

Assoc Physician

University of California, San Diego

Study Sites (2)

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