Antibiotic-induced Disruption of the Microbiota

Recruiting

• Conditions: Microbiota; Antibiotic Disruption

• Registration Number: NCT04091282
• Lead Sponsor: University of Fribourg

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.

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Study Start: 2020-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibiotic-induced disruption of breast milk microbiota	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.
Antibiotic-Induced disruption the infant stool microbiota	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.
Maternal to infant microbiota transfer	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.
The composition of the intestinal microbiota and adverse health outcomes	2 years	Abundance of certain microbes in the intestinal microbiota and weight (in kg) at 1 and 2 years of age

Secondary Outcome Measures

Name	Time	Method
Antibiotic-Induced disruption the infant stool microbiota	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.
Antibiotic-induced disruption of breast milk microbiota	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.
Introduction of different foods affects the composition of the intestinal microbiota	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.
Administration of oxygen affects the composition of the intestinal microbiota in infants	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.
Administration of antacids affect the composition of the infant intestinal microbiota	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.

Trial Locations

Locations (1)

Hopital cantonal Fribourg; 🇨🇭 Fribourg, Switzerland