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

Not Applicable

Recruiting

• Conditions: Healthy Newborn Infants

• Registration Number: NCT06974994
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-08
• Study First Submitted: 2025-04-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BMI at 24 months of age	From enrollment to 24 months of age	Child's body mass index (BMI) at the age of 24 months

Secondary Outcome Measures

Name	Time	Method
Hormonal levels	From enrollment to 6 months of age	Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months
Mother's microbiome	From enrollment to 6 months after giving birth	The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age
Respiratory tract infections	From enrollment to 24 months of age	Respiratory tract infections by the age of 24 months
Height	From enrollment to 24 months of age	Child's height at the age of 6, 12, 18, and 24 months
Breast milk microbiome	From enrollment to 6 months of age	The composition of breast milk's microbiome when the child is 2 and 6 months of age
Weight	From enrollment to 24 months of age	Child's weight at the age of 6, 12, 18, and 24 months
Growth velocity	From enrollment to 3 months of age	Child's growth velocity at 2-3 months of age
Inflammatory markers	From enrollment to 6 months of age	Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months
Child's microbiome	From enrollment to 24 months of age	The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months

Trial Locations

Locations (1)

Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku; 🇫🇮 Turku, Valitse maakunta., Finland