Antibiotic-induced Disruption of the Microbiota

NCT ID: NCT04091282

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-25

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Microbiota Antibiotic Disruption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Fribourg

OTHER

Sponsor Role lead

Responsible Party

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Petra Zimmermann

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petra Zimmermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Cantonal de Fribourg, Switzerland

Locations

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Hopital cantonal Fribourg

Fribourg, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Petra Zimmermann, MD, PhD

Role: CONTACT

+413063542

Facility Contacts

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Petra Zimmermann, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32580987 (View on PubMed)

Other Identifiers

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2019 - 01567

Identifier Type: -

Identifier Source: org_study_id

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