Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synbiotic Supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Newborn Infants. Basic parameters: from 2 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
Overview
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.
Interventions
- Dietary supplement Synbiotic Supplement
Bifidobacterium bifidum and human milk oligosaccharides (HMOs) - Other Placebo
Maltodextrin
Primary outcome measures
- BMI at 24 months of age [Time frame: From enrollment to 24 months of age]
Secondary outcome measures (9)
- Height [Time frame: From enrollment to 24 months of age]
- Weight [Time frame: From enrollment to 24 months of age]
- Growth velocity [Time frame: From enrollment to 3 months of age]
- Child's microbiome [Time frame: From enrollment to 24 months of age]
- Mother's microbiome [Time frame: From enrollment to 6 months after giving birth]
- Breast milk microbiome [Time frame: From enrollment to 6 months of age]
- Hormonal levels [Time frame: From enrollment to 6 months of age]
- Inflammatory markers [Time frame: From enrollment to 6 months of age]
- Respiratory tract infections [Time frame: From enrollment to 24 months of age]
Eligibility criteria
Inclusion criteria
Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Finland · 1 center
- Department of Paediatrics and Adolescent Medicine, Turku University Hospital and Universit — Turku
Identifiers
NCT: NCT06974994 · T1927_2023