Clinical trial NCT04091282: Antibiotic-induced Disruption of the Microbiota
Official title: Antibiotic-induced Disruption of the Maternal and Infant Microbiota and Adverse Health Outcomes - The ABERRANT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microbiota
Antibiotic Disruption
Keywords: Metagenome
Infants
Lead sponsor: University of Fribourg
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who give birth at the Hôpital fribourgeois (HFR) in Fribourg, Switzerland and their infants.

Brief summary: The use of antibiotics causes profound changes in the microbiota. However, the magnitude of the effect of intrapartum and early-life antibiotics on the breast milk and the infant oral and intestinal microbiota, and whether effects are only short-term or persist long-term remain uncertain and will be determined in this study.

Detailed description: In this prospective cohort study, the investigators will determine the effect of (i) intrapartum antibiotics on the composition of the breast milk, and the infant oral and intestinal microbiota and antibiotic exposure in the first year of life on the composition of the infant intestinal microbiota (including the development and persistence of antibiotic resistance) and (ii) the association of this disruption with adverse health outcomes. (iii) The investigators will also determine the association between the maternal intestinal microbiota, the breast milk microbiota and the infant oral and intestinal microbiota.

Eligibility criteria: Inclusion Criteria:

* healthy infants
* term infants (\> 37 weeks of gestation)

Exclusion Criteria:

* maternal HIV infection
* maternal hepatitis B or C infection
* antibiotics in the third trimester of pregnancy
* intake of probiotics during pregnancy
* infants with the low birth weight \<2500 g
* infants with congenital abnormality

Primary outcomes:
measure: Antibiotic-induced disruption of breast milk microbiota
timeFrame: 2 years
measure: Antibiotic-Induced disruption the infant stool microbiota
timeFrame: 2 years
measure: Maternal to infant microbiota transfer
timeFrame: 2 years
measure: The composition of the intestinal microbiota and adverse health outcomes
timeFrame: 2 years
measure: The composition of the intestinal microbiota and adverse health outcomes
timeFrame: 2 years
measure: The composition of the intestinal microbiota and adverse health outcomes
timeFrame: 2 years
measure: The composition of the intestinal microbiota and adverse health outcomes
timeFrame: 2 years
Secondary outcomes:
measure: Antibiotic-induced disruption of breast milk microbiota
timeFrame: 2 years
measure: Antibiotic-Induced disruption the infant stool microbiota
timeFrame: 2 years
measure: Introduction of different foods affects the composition of the intestinal microbiota
timeFrame: 2 years
measure: Administration of oxygen affects the composition of the intestinal microbiota in infants
timeFrame: 2 years
measure: Administration of antacids affect the composition of the infant intestinal microbiota
timeFrame: 2 years
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Hopital cantonal Fribourg
Study officials:
affiliation: Hopital Cantonal de Fribourg, Switzerland
name: Petra Zimmermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volery M, Scherz V, Jakob W, Bandeira D, Deggim-Messmer V, Lauber-Biason A, Wildhaber J, Falquet L, Curtis N, Zimmermann P. Study protocol for the ABERRANT study: antibiotic-induced disruption of the maternal and infant microbiome and adverse health outcomes - a prospective cohort study among children born at term. BMJ Open. 2020 Jun 23;10(6):e036275. doi: 10.1136/bmjopen-2019-036275.