Intestinal Microbiota Composition After Antibiotic Treatment in Early Life
NCT ID: NCT02536560
Last Updated: 2015-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
450 participants
OBSERVATIONAL
2012-01-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
NCT06850896
The URT and Middle Ear Microbiota in Health and During Chronic OME
NCT03109496
Study of the Intestinal Microbiota
NCT07058961
Impact of Prolonged Antibiotic Therapy on Commensal Microbial Community Gene Expression.
NCT05169255
Prevalence of Enterobacteria With Decreased Susceptibility to Carbapenems in Eastern Inter- Region
NCT02803710
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Antibiotics
150 infants, (because of hospital protocol) treated with antibiotics because of a perinatal infection during the first week of life
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment
3. Signed informed consent by the parents
Exclusion Criteria
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.
1 Hour
7 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Danone Global Research & Innovation Center
INDUSTRY
Amsterdam UMC, location VUmc
OTHER
Agentschap NL
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicole B.M.M. Rutten
PhD candidate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arine M Vlieger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St Antonius Hospital Nieuwegein, the Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gelre Hospitals
Apeldoorn, Gelderland, Netherlands
Meander Medical Centre
Amersfoort, Utrecht, Netherlands
Tergooi Hospital
Blaricum, Utrecht, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL.37233.100.11, R-11.26AM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.