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AtopyMAPNCT04835935

Microbiome, Atopic Disease, Prematurity

An observational study of Atopy and Prematurity, run by Sydney Leibel at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 7 days
Conditions the study is for
Atopy, Prematurity
What is being tested?
microbiome pattern
How many people
51 participants
Where
2 sitesUnited States
Study dates
1 Jun 2019to 30 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 7 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: Premature infants born at equal or less than 34 weeks gestational age.

Who may be able to join

  • premature infant equal or less than 34 weeks of age

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Scripps Memorial Hospital - Rady NICU

    San Diego, California, 92037

  • University of California, San Diego - Jacobs NICU

    San Diego, California, 92093

Other trials in United States

About this study

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

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:

Read more
  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.

Conditions
Atopy, Prematurity
Being tested
microbiome pattern
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microbiome patternOther

    microbiome pattern in neonatal period

Study groups in NCT04835935
Study groupRoleWhat they receive
subject who developed atopic diseaseNot described
Receives: Other: microbiome pattern
subject who did not develop atopic diseaseNot described
Receives: Other: microbiome pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pediatric Atopic Disease

    Clinical diagnosis of any atopic disease among the participants during study follow up visit. These include any food allergies, allergic rhinitis, eczema, and asthma.

    Measured: 2-3 years of age

Secondary outcomes (1)

  1. Allergic sensitization patterns

    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.

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 Jun 2019
  3. Primary completion1 Nov 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835935
Sponsor's protocol ID
181711
Acronym
MAP
Status last verified
Feb 2025
First submitted
2 Mar 2021
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: de-identified microbiome and metabolome data will be available.

Publications

  • Raciborski F, Tomaszewska A, Komorowski J, Samel-Kowalik P, Bialoszewski AZ, Walkiewicz A, Lusawa A, Szymanski J, Opoczynska D, Druzba M, Borowicz J, Lipiec A, Kapalczynski WJ, Samolinski B. The relationship between antibiotic therapy in early childhood and the symptoms of allergy in children aged 6-8 years - the questionnaire study results. Int J Occup Med Environ Health. 2012 Sep;25(4):470-80. doi: 10.2478/S13382-012-0056-0. Epub 2012 Dec 3.

    PubMed 23212289

  • Silvers KM, Frampton CM, Wickens K, Pattemore PK, Ingham T, Fishwick D, Crane J, Town GI, Epton MJ; New Zealand Asthma and Allergy Cohort Study Group. Breastfeeding protects against current asthma up to 6 years of age. J Pediatr. 2012 Jun;160(6):991-6.e1. doi: 10.1016/j.jpeds.2011.11.055. Epub 2012 Jan 30.

    PubMed 22289356

  • Roduit C, Scholtens S, de Jongste JC, Wijga AH, Gerritsen J, Postma DS, Brunekreef B, Hoekstra MO, Aalberse R, Smit HA. Asthma at 8 years of age in children born by caesarean section. Thorax. 2009 Feb;64(2):107-13. doi: 10.1136/thx.2008.100875. Epub 2008 Dec 3.

    PubMed 19052046

  • Been JV, Lugtenberg MJ, Smets E, van Schayck CP, Kramer BW, Mommers M, Sheikh A. Preterm birth and childhood wheezing disorders: a systematic review and meta-analysis. PLoS Med. 2014 Jan 28;11(1):e1001596. doi: 10.1371/journal.pmed.1001596. eCollection 2014 Jan.

    PubMed 24492409

  • Lynch SV, Wood RA, Boushey H, Bacharier LB, Bloomberg GR, Kattan M, O'Connor GT, Sandel MT, Calatroni A, Matsui E, Johnson CC, Lynn H, Visness CM, Jaffee KF, Gergen PJ, Gold DR, Wright RJ, Fujimura K, Rauch M, Busse WW, Gern JE. Effects of early-life exposure to allergens and bacteria on recurrent wheeze and atopy in urban children. J Allergy Clin Immunol. 2014 Sep;134(3):593-601.e12. doi: 10.1016/j.jaci.2014.04.018. Epub 2014 Jun 4.

    PubMed 24908147

  • Arrieta MC, Stiemsma LT, Dimitriu PA, Thorson L, Russell S, Yurist-Doutsch S, Kuzeljevic B, Gold MJ, Britton HM, Lefebvre DL, Subbarao P, Mandhane P, Becker A, McNagny KM, Sears MR, Kollmann T; CHILD Study Investigators; Mohn WW, Turvey SE, Finlay BB. Early infancy microbial and metabolic alterations affect risk of childhood asthma. Sci Transl Med. 2015 Sep 30;7(307):307ra152. doi: 10.1126/scitranslmed.aab2271.

    PubMed 26424567

  • Jeurink PV, van Esch BC, Rijnierse A, Garssen J, Knippels LM. Mechanisms underlying immune effects of dietary oligosaccharides. Am J Clin Nutr. 2013 Aug;98(2):572S-7S. doi: 10.3945/ajcn.112.038596. Epub 2013 Jul 3.

    PubMed 23824724

  • Neu J. Preterm infant nutrition, gut bacteria, and necrotizing enterocolitis. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):285-8. doi: 10.1097/MCO.0000000000000169.

    PubMed 25807349

  • Luskin K, Mortazavi D, Bai-Tong S, Bertrand K, Chambers C, Schulkers-Escalante K, Ahmad A, Luedtke S, O'Donoghue AJ, Ghassemian M, Geng B, Leibel SL, Leibel SA. Allergen Content and Protease Activity in Milk Feeds from Mothers of Preterm Infants. Breastfeed Med. 2022 Nov;17(11):947-957. doi: 10.1089/bfm.2022.0115. Epub 2022 Oct 12.

    PubMed 36251466

Questions about this trial

What is this clinical trial studying?

An observational study of Atopy and Prematurity, run by Sydney Leibel at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Atopic Disease (time frame: 2-3 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835935, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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