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Intestinal Microbiota Composition After Antibiotic Treatment in Early Life (INCA)

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ClinicalTrials.gov Identifier: NCT02536560
Recruitment Status : Unknown
Verified August 2015 by Nicole B.M.M. Rutten, Agentschap NL.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Collaborators:
Danone Research
Amsterdam UMC, location VUmc
Information provided by (Responsible Party):
Nicole B.M.M. Rutten, Agentschap NL

Tracking Information
First Submitted Date August 21, 2015
First Posted Date September 1, 2015
Last Update Posted Date September 1, 2015
Study Start Date January 2012
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2015)
Clinical endpoints [ Time Frame: Participants will be followed during their first year of life ]
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 28, 2015)
  • Microbiota composition [ Time Frame: Samples will be taken at eight time points during the participant's first year of life ]
    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).
  • Vaccine response [ Time Frame: around 1 year of age ]
    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.
  • Doctor's diagnosis [ Time Frame: Participants will be followed during their first year of life ]
    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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2015)
  • infant height [ Time Frame: Participant's height is monitored during the first year of life ]
    Individual height is monitored during the first year of life. Parents report the most recently measured height of the child on the calendar lists. (height is measured in centimeters)
  • infant weight [ Time Frame: Participant's weight is monitored during the first year of life ]
    Individual weight is monitored during the first year of life. Parents report the most recently measured weight of the child on the calendar lists. (weight is measured in kilograms)
  • coughing [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: The child coughs several times a day and/or has coughing. Regularly there are signs of cold. Cough because of choking does not have to be recorded.
  • wheezing [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: During expiration the parents notice a whistling, wheezy sound coming from the lower airways of the child. During expiration the child is trying to squeeze the air outwards. Wheezing coming from or through the nose does not have to be recorded.
  • fever >38 degrees Celsius [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: Clear from itself, whereby it is important that parents use a rectal thermometer, measure twice and the temperature is >38 degrees Celsius on both occasions.
  • runny nose [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: Signs of cold with white/yellow/green mucus running from the nose.
  • glue ear [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: The child seems to have earache and/or grasps its ear (the ear frequently is high-colored or bends) and/or glue egresses from the ear.
  • rash [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: More than one day existing skin-redness (spots, rash, pimples) on the face, arms or legs, trunk. Disease-symptoms are not necessarily present. The rash can be eczema; eczema mostly is red, scaly and may itch. Infants cheeks are affected mostly. When children grow up, elbow and knees are preferred sites.
  • diarrhea [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: Watery or mucous defecation, more than three times a day, that continues more than one day.
  • >3 crying hours a day [ Time Frame: 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 ]
    Parental reported symptom on calendar list (yes/no). Description: Clear from itself, whereby the total crying episodes add up to more than three hours a day (24 hours) in total.
  • prescribed antibiotics [ Time Frame: Participants will be followed during their first year of life and prescription of antibiotic courses will be monitored ]
    Any prescribed (systemic) antibiotic treatments during the first year of life are investigated. Measured as number of antibiotic courses during the first year of life, [1] parental reported (on the calendar list) and [2] checked via pharmacist's medication records.
  • allergic sensitization [ Time Frame: around 1 year of age ]
    (serum) allergen antibodies to food and inhalant allergens are determined. Measured in kilo unit.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Intestinal Microbiota Composition After Antibiotic Treatment in Early Life
Official Title "Intestinal Microbiota Composition After Antibiotic Treatment in Early Life. The INCA Study"
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.

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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
faecal samples
Sampling Method Non-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
Condition
  • Microbiota
  • Eczema
  • Atopy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 28, 2015)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Congenital illness or malformations
  2. Severe perinatal infections for which transfer to the neonatal intensive care unit is needed
  3. Maternal probiotic use ≤ six weeks before delivery
  4. Insufficient knowledge of the Dutch language.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Hour to 7 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536560
Other Study ID Numbers NL.37233.100.11, R-11.26AM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Nicole B.M.M. Rutten, Agentschap NL
Original Responsible Party Same as current
Current Study Sponsor Agentschap NL
Original Study Sponsor Same as current
Collaborators
  • Danone Research
  • Amsterdam UMC, location VUmc
Investigators
Principal Investigator: Arine M Vlieger, MD, PhD St Antonius Hospital Nieuwegein, the Netherlands
PRS Account Agentschap NL
Verification Date August 2015