Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotic-induced Disruption of the Microbiota (ABERRANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091282
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Petra Zimmermann, 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.

Condition or disease Intervention/treatment
Microbiota Antibiotic Disruption Other: No intervention

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibiotic-induced Disruption of the Maternal and Infant Microbiota and Adverse Health Outcomes - The ABERRANT Study
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.


Biospecimen Retention:   Samples Without DNA
Stool, oral swabs, breast milk, blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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
  • infants exposed to probiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091282


Contacts
Layout table for location contacts
Contact: Petra Zimmermann, MD +413063542 petra.zimmermann@h-fr.ch

Sponsors and Collaborators
University of Fribourg

Layout table for additonal information
Responsible Party: Petra Zimmermann, Principal investigator, University of Fribourg
ClinicalTrials.gov Identifier: NCT04091282     History of Changes
Other Study ID Numbers: 2019 - 01567
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Petra Zimmermann, University of Fribourg:
Metagenome
Infants
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents