NCT02536560

Brief Summary

In this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an important underlying mechanism for impediments in the developing immune system. Differentiation will be made between a group of neonates who received antibiotics in the first week of life, and control infants who were not exposed to antibiotics in the neonatal period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4.3 years

First QC Date

August 21, 2015

Last Update Submit

August 28, 2015

Conditions

MicrobiotaEczemaAtopy

Keywords

intestinal microbiotaantibioticsinfantallergy

Outcome Measures

Primary Outcomes (1)

  • Clinical endpoints

    Differences in clinical outcomes between antibiotic treated infants and controls are investigated. Incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), gastrointestinal infections (GITI) and excessive crying are evaluated. Data are prospectively assessed by parental reports (calendar lists).

    Participants will be followed during their first year of life

Secondary Outcomes (3)

  • Microbiota composition

    Samples will be taken at eight time points during the participant's first year of life

  • Vaccine response

    around 1 year of age

  • Doctor's diagnosis

    Participants will be followed during their first year of life

Other Outcomes (12)

  • infant height

    Participant's height is monitored during the first year of life

  • infant weight

    Participant's weight is monitored during the first year of life

  • coughing

    the symptom is daily reported as present or not present (by the parents, on the calendar list), during the infant's first year of life

  • +9 more other outcomes

Study Arms (2)

Antibiotics

150 infants, (because of hospital protocol) treated with antibiotics because of a perinatal infection during the first week of life

Controls

The control group comprises 300 healthy newborns, born in the hospital and needing clinical observation for 24-48 hours for several reasons like maternal comorbidity, low probability of neonatal infection, blood sugar monitoring, meconium containing amniotic fluid, or delivery by caesarean section

Eligibility Criteria

Age1 Hour - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy newborns born in the hospital, observed for low probability of neonatal infection will be compared to newborns exposed to antibiotic therapy in early life (first 1-2 weeks) by investigating potential differences in intestinal fecal microbiota composition

You may qualify if:

  • Term-born babies (≥ 36 weeks gestational age)
  • (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment
  • Signed informed consent by the parents

You may not qualify if:

  • Congenital illness or malformations
  • Severe perinatal infections for which transfer to the neonatal intensive care unit is needed
  • Maternal probiotic use ≤ six weeks before delivery
  • Insufficient knowledge of the Dutch language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gelre Hospitals

Apeldoorn, Gelderland, 7334 DZ, Netherlands

RECRUITING

Meander Medical Centre

Amersfoort, Utrecht, 3813 TZ, Netherlands

RECRUITING

Tergooi Hospital

Blaricum, Utrecht, 1261 AN, Netherlands

RECRUITING

St Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

RECRUITING

Related Publications (6)

  • Daele EV, Kamphorst K, Belzer C, van Elburg RM, Knol J, Smidt H, Vlieger AM. Aberrant microbiota signatures precede symptom development in infantile colic. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):217-225. doi: 10.1002/jpn3.70101. Epub 2025 Jun 9.

    PMID: 40485532DERIVED

  • An R, Fontana F, Van Daele E, Ventura M, Vlieger A, van Elburg RM, Knol J, Milani C, Belzer C. Longitudinal changes in bifidobacterial population during the first two years of life. Benef Microbes. 2024 Apr 30;15(3):227-240. doi: 10.1163/18762891-bja00012.

    PMID: 38677714DERIVED

  • Kamphorst K, Vlieger AM, Oosterloo BC, Garssen J, van Elburg RM. Neonatal Antibiotics and Food Allergy Are Associated With FGIDs at 4-6 Years of Age. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):770-775. doi: 10.1097/MPG.0000000000003428. Epub 2022 Feb 24.

    PMID: 35588166DERIVED

  • Oosterloo BC, Van't Land B, de Jager W, Rutten NB, Klopping M, Garssen J, Vlieger AM, van Elburg RM. Neonatal Antibiotic Treatment Is Associated With an Altered Circulating Immune Marker Profile at 1 Year of Age. Front Immunol. 2020 Jan 10;10:2939. doi: 10.3389/fimmu.2019.02939. eCollection 2019.

    PMID: 31998285DERIVED

  • Kamphorst K, Oosterloo BC, Vlieger AM, Rutten NB, Bunkers CM, Wit EC, van Elburg RM. Antibiotic Treatment in the First Week of Life Impacts the Growth Trajectory in the First Year of Life in Term Infants. J Pediatr Gastroenterol Nutr. 2019 Jul;69(1):131-136. doi: 10.1097/MPG.0000000000002360.

    PMID: 31058782DERIVED

  • Rutten NB, Rijkers GT, Meijssen CB, Crijns CE, Oudshoorn JH, van der Ent CK, Vlieger AM. Intestinal microbiota composition after antibiotic treatment in early life: the INCA study. BMC Pediatr. 2015 Dec 9;15:204. doi: 10.1186/s12887-015-0519-0.

    PMID: 26645894DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

faecal samples

MeSH Terms

Conditions

EczemaHypersensitivity

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousImmune System Diseases

Study Officials

  • Arine M Vlieger, MD, PhD

    St Antonius Hospital Nieuwegein, the Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole B Rutten, MD

CONTACT

+31 88 320 6325n.rutten@antoniusziekenhuis.nl

Arine M Vlieger, MD, PhD

CONTACT

+31 88 320 6325a.vlieger@antoniusziekenhuis.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 1, 2015

Study Start

January 1, 2012

Primary Completion

April 1, 2016

Study Completion

October 1, 2016

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

NL(4)