NCT Number: NCT06974994
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.
Interested in participating?
Request Info2 hour and older
All sexes
Interventional
Not applicable
Turku, Valitse Maakunta., 20780, Finland
Location status: Recruiting
Erika Isolauri, MD, PhD
PRINCIPAL_INVESTIGATOR
Paula Tähtinen, MD, PhD
CONTACT
Paula Tähtinen, MD, PhD
SUB_INVESTIGATOR
Tuuli Vuorisalo, MD
SUB_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Exclusion criteria
Bifidobacterium bifidum and human milk oligosaccharides (HMOs)
Maltodextrin
Time frame: From enrollment to 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
Child's height at the age of 6, 12, 18, and 24 months
Time frame: From enrollment to 24 months of age
Child's weight at the age of 6, 12, 18, and 24 months
Time frame: From enrollment to 3 months of age
Child's growth velocity at 2-3 months of age
Time frame: 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
Time frame: 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
Time frame: From enrollment to 6 months of age
The composition of breast milk's microbiome when the child is 2 and 6 months of age
Time frame: 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
Time frame: 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
Time frame: From enrollment to 24 months of age
Respiratory tract infections by the age of 24 months
Contact information is provided by the study sponsor or research team.
Turku University Hospital
Other Gov
Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
Acronym: ReCoverHealth
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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