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MicrobiotaABERRANTNCT04091282

Antibiotic-induced Disruption of the Microbiota

An observational study of Microbiota and Antibiotic Disruption, run by University of Fribourg at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 1 day to 2 yearsHealthy volunteers can take part
Conditions the study is for
Microbiota, Antibiotic Disruption
How many people
400 participants
Where
1 siteSwitzerland
Study dates
25 Jan 2020to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 2 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Petra Zimmermann, MD, PhD contact

+413063542

petra.zimmermann@h-fr.ch

Switzerland1 site, 1 recruiting

  • Hopital cantonal Fribourg

    Fribourg, 1700

    Petra Zimmermann, MD, PhD

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
No intervention
Keywords
Metagenome, Infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. 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

    Measured: 2 years

  6. 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

    Measured: 2 years

  7. 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

    Measured: 2 years

Secondary outcomes (5)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start25 Jan 2020
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091282
Sponsor's protocol ID
2019 - 01567
Other IDs
2019
Acronym
ABERRANT
Status last verified
Apr 2024
First submitted
28 Aug 2019
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32580987

Questions about this trial

What is this clinical trial studying?

An observational study of Microbiota and Antibiotic Disruption, run by University of Fribourg at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Petra Zimmermann, MD, PhD (+413063542, petra.zimmermann@h-fr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibiotic-induced disruption of breast milk microbiota (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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