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MicrobiotaINCANCT02536560

Intestinal Microbiota Composition After Antibiotic Treatment in Early Life

An observational study of Microbiota and Eczema, run by Agentschap NL at 4 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 hour to 7 daysHealthy volunteers can take part
Conditions the study is for
Microbiota, Eczema, Atopy
How many people
450 participants
Where
4 sitesNetherlands
Study dates
Jan 2012to Oct 2016
Phase
Observational
Are there results?
None posted in the registry

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 1 hour to 7 days
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Nicole B Rutten, MD contact

+31 88 320 6325

n.rutten@antoniusziekenhuis.nl

Arine M Vlieger, MD, PhD contact

+31 88 320 6325

a.vlieger@antoniusziekenhuis.nl

Netherlands4 sites, 4 recruiting

  • Meander Medical Centre

    Amersfoort, Utrecht, 3813 TZ

    Clemens B Meijssen, MD, +31 33 850 5050, CB.Meijssen@meandermc.nl

    Recruiting

  • Gelre Hospitals

    Apeldoorn, Gelderland, 7334 DZ

    Johanna H Oudshoorn, MD, PhD, +31 55 581 8181, a.oudshoorn@gelre.nl

    Recruiting

  • Tergooi Hospital

    Blaricum, Utrecht, 1261 AN

    Clarissa E Crijns, MD, 088 753 1753, ce.crijns@yahoo.com

    Recruiting

  • St Antonius Hospital

    Nieuwegein, Utrecht, 3430 EM

    Arine M Vlieger, MD, PhD, +31 88 320 6325, a.vlieger@antoniusziekenhuis.nl

    Carin Bunkers, +31 88 320 6325, k.bunkers@antoniusziekenhuis.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: "Intestinal Microbiota Composition After Antibiotic Treatment in Early Life. The INCA Study"

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.

Read the detailed description

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).

Infants are recruited from the maternity wards and neonatal wards of four teaching hospitals in the Netherlands. In total 150 infants, treated with antibiotics because of (a high suspicion of) a perinatal infection during the first week of life, will be recruited. 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.

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, prospectively assessed by parental reports and retrospectively assessed by doctor's diagnoses. The clinical endpoints will be linked to the developing intestinal microbiota during the first year of life.

Potential differences in intestinal fecal microbiota composition and diversity can be determined at eight time points during the first year of life, as sampling moments include: day one (T1), day two (T2), one week (T3), two weeks (T4), one month (T5), three months (T6), six months (T7), one year (T8).

Conditions
Microbiota, Eczema, Atopy
Keywords
intestinal microbiota, antibiotics, infant, allergy
Medical subject headings
Eczema, Hypersensitivity

What participants receive

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

Study groups in NCT02536560
Study groupRoleWhat they receive
Antibiotics150 infants, (because of hospital protocol) treated with antibiotics because of a perinatal infection during the first week of life
ControlsThe 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

What is being measured

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

  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).

    Measured: Participants will be followed during their first year of life

Secondary outcomes (3)

  1. Microbiota composition

    Fecal bacterial composition and diversity is determined at eight time points during the first year of life, from birth on. Sampling points include: day one (T1), day two (T2), one week (T3), two weeks (T4), one month (T5), three months (T6), six months (T7), one year (T8).

    Potential differences in microbiota composition and diversity will be determined by use of 16S-23S ribosomal ribonucleic acid (rRNA) gene analysis (IS-pro).

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

  2. Vaccine response

    Immunoglobulin G antibodies against Tetanus toxoid, Diphtheria toxoid, Haemophilus influenza type B, and the capsular polysaccharides of the pneumococcal 10-valent conjugate vaccine will be determined.

    Antibody concentrations will be determined from blood samples. Measured in international units per milliliter or microgram per milliliter.

    Measured: around 1 year of age

  3. Doctor's diagnosis

    Diagnoses are defined by selected International Classification system of Primary Care (ICPC) codes, diagnosticated during the first year of life.

    These include: dyspnea (R02), wheezing (R03), cough (R05), acute upper tract infection (R74), acute bronchi(oli)tis (R78), pneumonia (R81), asthma like symptoms (R96), breath problems [R04], sneeze [R07], other symptoms of the nose [R08], symptoms of the throat [R21], abnormal sputum [R25], concern about respiratory illness [R27], acute laryngitis [R77], influenza [R88], other infections of the airways [R83], and other respiratory diseases [R99], infectious diarrhea (D70), vomiting (D10), susceptible gastro-intestinal infection (D73), other symptoms/complaints of the skin (S21), dry skin/ flaking (S21.01), infantile colic (A14).

    Measured: Participants will be followed during their first year of life

Timeline

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

  1. First posted1 Sep 2015 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2016 (estimated)
  4. Study completionOct 2016 (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
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536560
Sponsor's protocol ID
NL.37233.100.11, R-11.26AM
Acronym
INCA
Status last verified
Aug 2015
First submitted
21 Aug 2015
Last updated
1 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40485532

  • 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.

    PubMed 38677714

  • 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.

    PubMed 35588166

  • 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.

    PubMed 31998285

  • 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.

    PubMed 31058782

  • 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.

    PubMed 26645894

Questions about this trial

What is this clinical trial studying?

An observational study of Microbiota and Eczema, run by Agentschap NL at 4 sites in Netherlands.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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?

Results are not available in the source record.

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

Contact Nicole B Rutten, MD (+31 88 320 6325, n.rutten@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical endpoints (time frame: Participants will be followed during their first year of life). 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 NCT02536560, which also lists 6 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 1 Sep 2015.

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