Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorTurku University Hospital

About this trial

The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Chorioamnionitis

Pre-eclampsia and hepatogestosis

Suspected malformation or serious condition of the foetus and neonates

Serious infection or other conditions not permitting breast milk feeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Synbiotic Supplement

    Dietary supplement

    Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

  • Placebo

    Other intervention

    Maltodextrin

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: SynbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMI at 24 months of age

Child's body mass index (BMI) at the age of 24 months

Time frame
From enrollment to 24 months of age

Secondary outcomes

1

Height

Child's height at the age of 6, 12, 18, and 24 months

Time frame
From enrollment to 24 months of age
2

Weight

Child's weight at the age of 6, 12, 18, and 24 months

Time frame
From enrollment to 24 months of age
3

Growth velocity

Child's growth velocity at 2-3 months of age

Time frame
From enrollment to 3 months of age
4

Child's microbiome

The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months

Time frame
From enrollment to 24 months of age

Other outcomes

Sponsors and contacts

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Turku University Hospital

Lead sponsor

Lallemand Health Solutions

Collaborator