Exploring how synbiotics can modify the microbiota in newborns exposed to antibiotics
Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
This study is testing if giving a special supplement to newborns who received antibiotics can change their gut bacteria and help lower their chances of obesity and other health issues later on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 2 Hours and up |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku, Valitse Maakunta.) |
| Trial ID | NCT06974994 on ClinicalTrials.gov |
What this trial studies
This study investigates whether administering a synbiotic supplement to newborns exposed to antibiotics at birth can alter their microbiota and potentially lower the risk of obesity and chronic diseases. A total of 125 mother-child pairs will be enrolled in a randomized, double-blind, placebo-controlled design, where infants will receive either the synbiotic or a placebo for two months. Following the intervention, the growth and health of the infants will be monitored for two years to assess the long-term effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women and their newborns who are receiving antibiotic treatment at delivery.
Not a fit: Patients who have conditions such as chorioamnionitis, pre-eclampsia, or serious infections that prevent breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of obesity and chronic diseases in infants exposed to antibiotics.
How similar studies have performed: While this approach is innovative, similar studies exploring the impact of microbiota modulation on health outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turku, Valitse Maakunta.
- Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku — Turku, Valitse Maakunta., Finland (Recruiting)
Study contacts
- Study coordinator: Paula Tähtinen, MD, PhD
- Email: paula.tahtinen@utu.fi
- Phone: +358-2-3130746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.