Antibiotic-induced Disruption of the Microbiota (ABERRANT)

April 10, 2024 updated by: Petra Zimmermann, University of Fribourg

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Fribourg, Switzerland, 1700
        • Recruiting
        • Hopital cantonal Fribourg
        • Contact:
          • Petra Zimmermann, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who give birth at the Hôpital fribourgeois (HFR) in Fribourg, Switzerland and their infants.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic-induced disruption of breast milk microbiota
Time Frame: 2 years
Composition of breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
2 years
Antibiotic-Induced disruption the infant stool microbiota
Time Frame: 2 years
Composition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
2 years
Maternal to infant microbiota transfer
Time Frame: 2 years
Similarities 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.
2 years
The composition of the intestinal microbiota and adverse health outcomes
Time Frame: 2 years
Abundance of certain microbes in the intestinal microbiota and number of episodes of lower respiratory tract infections until 2 years of age
2 years
The composition of the intestinal microbiota and adverse health outcomes
Time Frame: 2 years
Abundance of certain microbes in the intestinal microbiota and number of episodes of acute otitis media episodes until 2 years of age
2 years
The composition of the intestinal microbiota and adverse health outcomes
Time Frame: 2 years
Abundance of certain microbes in the intestinal microbiota and prevalence of allergic sensitisation (positive skin prick test) at 1 and 2 years of age
2 years
The composition of the intestinal microbiota and adverse health outcomes
Time Frame: 2 years
Abundance of certain microbes in the intestinal microbiota and weight (in kg) at 1 and 2 years of age
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic-induced disruption of breast milk microbiota
Time Frame: 2 years
Prevalence 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.
2 years
Antibiotic-Induced disruption the infant stool microbiota
Time Frame: 2 years
Prevalence 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.
2 years
Introduction of different foods affects the composition of the intestinal microbiota
Time Frame: 2 years
Age (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.
2 years
Administration of oxygen affects the composition of the intestinal microbiota in infants
Time Frame: 2 years
Number 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.
2 years
Administration of antacids affect the composition of the infant intestinal microbiota
Time Frame: 2 years
Number 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Fribourg

Investigators

  • Principal Investigator: Petra Zimmermann, MD, PhD, Hopital Cantonal de Fribourg, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2020

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019 - 01567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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