Microbiome, Atopic Disease, Prematurity

NCT04835935 | Active Not Recruiting

• 1 other identifier: 181711
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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. 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. 2.Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns.
3. 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.

Conditions

Atopy; Prematurity

Outcome Measures

Primary Outcomes (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.

  2-3 years of age

Secondary Outcomes (1)

• Allergic sensitization patterns

  1-2 years

Other Outcomes (1)

• Gut, oral and milk feed microbiome

  birth to 1 year of age

Study Arms (2)

subject who developed atopic disease

Other: microbiome pattern

subject who did not develop atopic disease

Other: microbiome pattern

Interventions

microbiome pattern OTHER

microbiome pattern in neonatal period

subject who developed atopic disease; subject who did not develop atopic disease

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• premature infant equal or less than 34 weeks of age

You may not qualify if:

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

Sponsors & Collaborators

• Sydney Leibel: lead

Study Sites (2)

Scripps Memorial Hospital - Rady NICU

San Diego, California, 92037, United States

Location

University of California, San Diego - Jacobs NICU

San Diego, California, 92093, United States

Location

Related Publications (9)

• 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.

  PMID: 23212289 BACKGROUND

• 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.

  PMID: 22289356 BACKGROUND

• 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.

  PMID: 19052046 BACKGROUND

• 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.

  PMID: 24492409 BACKGROUND

• 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.

  PMID: 24908147 BACKGROUND

• 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.

  PMID: 26424567 BACKGROUND

• 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.

  PMID: 23824724 BACKGROUND

• 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.

  PMID: 25807349 BACKGROUND

• 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.

  PMID: 36251466 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool, breast milk, saliva

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Physician

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: April 8, 2021
• Study Start: June 1, 2019
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)