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

Turku University Hospital (TYKS)

Status: Enrolling

Conditions: Healthy Newborn Infants

Treatments: Dietary Supplement: Synbiotic Supplement; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06974994

T1927_2023

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 2+ hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Synbiotic

Active Comparator group

Description:

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Treatment:

Dietary Supplement: Synbiotic Supplement

Placebo

Placebo Comparator group

Treatment:

Other: Placebo