NCT04835935: MAP

Microbiome, Atopic Disease, Prematurity

Active, enrolled Last updated 6 February 2025

What this trial tests

trial testing microbiome pattern in Atopy in 51 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2019

Primary endpoint
1 November 2030

30 December 2030

Quick facts

Lead sponsor	Sydney Leibel
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	51
Start date	1 June 2019
Primary completion	1 November 2030
Estimated completion	30 December 2030
Sites	2 locations across United States

Drugs / interventions tested

• microbiome pattern

Conditions studied

• Atopy — all drugs for Atopy →
• Prematurity — all drugs for Prematurity →

Sponsor

Sydney Leibel

Who can join

Adults 0 Days to 7 Days, any sex, with Atopy or Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The impact of maternal asthma on the preterm infants' gut metabolome and microbiome (MAP study).
   Bai-Tong SS, Thoemmes MS, Weldon KC, Motazavi D, et al · · 2022 · cited 4× · PMID 35440708 · DOI 10.1038/s41598-022-10276-y
2. The impact of breastfeeding on the preterm infant's microbiome and metabolome: a pilot study.
   Schulkers Escalante K, Bai-Tong SS, Allard SM, Ecklu-Mensah G, et al · · 2025 · cited 3× · PMID 39138352 · DOI 10.1038/s41390-024-03440-9
3. Allergen Content and Protease Activity in Milk Feeds from Mothers of Preterm Infants.
   Luskin K, Mortazavi D, Bai-Tong S, Bertrand K, et al · · 2022 · cited 1× · PMID 36251466 · DOI 10.1089/bfm.2022.0115