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Antibiotic-induced Disruption of the Microbiota

Antibiotic-induced Disruption of the Maternal and Infant Microbiota and Adverse Health Outcomes - The ABERRANT Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04091282
Acronym
ABERRANT
Enrollment
400
Registered
2019-09-16
Start date
2020-01-25
Completion date
2025-12-30
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Disruption, Microbiota

Keywords

Metagenome, 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

University of Fribourg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic-induced disruption of breast milk microbiota2 yearsComposition of breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Antibiotic-Induced disruption the infant stool microbiota2 yearsComposition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Maternal to infant microbiota transfer2 yearsSimilarities in the composition of the maternal intestinal, the breast milk microbiota and the infant intestinal microbiota, at 38 weeks of pregnancy, at birth and when infants are 7 days, 1, 2, 4 and 6 months of age.
The composition of the intestinal microbiota and adverse health outcomes2 yearsAbundance of certain microbes in the intestinal microbiota and number of episodes of lower respiratory tract infections until 2 years of age

Secondary

MeasureTime frameDescription
Antibiotic-induced disruption of breast milk microbiota2 yearsPrevalence of antibiotic resistance genes within the breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Antibiotic-Induced disruption the infant stool microbiota2 yearsPrevalence of antibiotic resistance genes within the intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Introduction of different foods affects the composition of the intestinal microbiota2 yearsAge (in days) when a new food item was introduced and composition of infant intestinal microbiota when infants are 1, 2, 4, 6, 12 and 24 months of age.
Administration of oxygen affects the composition of the intestinal microbiota in infants2 yearsNumber of days of oxygen and composition of infant intestinal microbiota when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Administration of antacids affect the composition of the infant intestinal microbiota2 yearsNumber of days antacids were administered and composition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.

Countries

Switzerland

Contacts

Primary ContactPetra Zimmermann, MD, PhD
petra.zimmermann@h-fr.ch+413063542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026