Antibiotic-induced Disruption of the Microbiota

NCT04091282 | Recruiting

• 1 other identifier: 2019 - 01567
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota; Antibiotic Disruption

Keywords

Metagenome; Infants

Outcome Measures

Primary Outcomes (7)

• Antibiotic-induced disruption of breast milk microbiota

  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

  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

  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

  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

  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

  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

  Abundance of certain microbes in the intestinal microbiota and weight (in kg) at 1 and 2 years of age

  2 years

Secondary Outcomes (5)

• Antibiotic-induced disruption of breast milk microbiota

  2 years

• Antibiotic-Induced disruption the infant stool microbiota

  2 years

• Introduction of different foods affects the composition of the intestinal microbiota

  2 years

• Administration of oxygen affects the composition of the intestinal microbiota in infants

  2 years

• Administration of antacids affect the composition of the infant intestinal microbiota

  2 years

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Fribourg: lead

Study Sites (1)

Hopital cantonal Fribourg

Fribourg, 1700, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 32580987 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, oral swabs, breast milk, blood

Study Officials

• Petra Zimmermann, MD, PhD

  Hopital Cantonal de Fribourg, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Zimmermann, MD, PhD

CONTACT

+413063542; petra.zimmermann@h-fr.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 16, 2019
• Study Start: January 25, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)