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Microbiome, Atopic Disease, Prematurity (MAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04835935
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : July 6, 2022
Information provided by (Responsible Party):
Sydney Leibel, University of California, San Diego

Tracking Information
First Submitted Date March 2, 2021
First Posted Date April 8, 2021
Last Update Posted Date July 6, 2022
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 5, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2021)
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title Microbiome, Atopic Disease, Prematurity
Official Title The Association Between Milk Feedings in the Preterm Population, the Microbiome and Risk of Atopic Disease
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Stool, breast milk, saliva
Sampling Method Non-Probability Sample
Study Population Premature infants born at equal or less than 34 weeks gestational age.
  • Atopy
  • Prematurity
Intervention Other: microbiome pattern
microbiome pattern in neonatal period
Study Groups/Cohorts
  • subject who developed atopic disease
    Intervention: Other: microbiome pattern
  • subject who did not develop atopic disease
    Intervention: Other: microbiome pattern
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 5, 2021)
Original Actual Enrollment Same as current
Estimated Study Completion Date June 30, 2025
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: All
Ages 0 Days to 7 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04835935
Other Study ID Numbers 181711
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: de-identified microbiome and metabolome data will be available.
Current Responsible Party Sydney Leibel, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor Sydney Leibel
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of California, San Diego
Verification Date July 2022