Antibiotic-induced Disruption of the Microbiota

Microbiota Clinical Trial

— ABERRANT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091282
• Other study ID #: 2019 - 01567
• Status: Recruiting
• Start date: January 25, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: University of Fribourg
• Contact: Petra Zimmermann, MD, PhD
• Phone: +413063542
• Email: petra.zimmermann[@]h-fr.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Disruption
• Microbiota

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Switzerland	Hopital cantonal Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Fribourg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Antibiotic-induced disruption of breast milk microbiota	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
Secondary	Antibiotic-Induced disruption the infant stool microbiota	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
Secondary	Introduction of different foods affects the composition of the intestinal microbiota	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
Secondary	Administration of oxygen affects the composition of the intestinal microbiota in infants	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
Secondary	Administration of antacids affect the composition of the infant intestinal microbiota	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