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Active, Not Recruiting

NCT Number: NCT04835935

Microbiome, Atopic Disease, Prematurity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Memorial Hospital - Rady NICU, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microbiome pattern

Other

microbiome pattern in neonatal period

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sydney Leibel

Other

Registry information

Official study title

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

Acronym: MAP

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Apr 8, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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