ECOBABe - Early Colonisation with Bacteria After Birth

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HYPOTHESIS - Oral administration of maternal vaginal microbiota in babies born by c-section (CS) will alter their gut microbiota so that they more closely resemble that of vaginally-born babies. AIMS - To explore whether oral administration of maternal vaginal microbiota in babies born by CS will: i) change the overall gut microbiota community structure, to more closely approximate gut microbiota of vaginally-born babies and ii) lead to strain transfer from mother to baby. BACKGROUND - While CS may cause acute complications, an increased risk of obesity and immune disorders in the offspring has also been identified. This association may be driven by disruption of the gut microbiota, which is essential for many host physiological processes. Contact with maternal vaginal microbes during vaginal delivery is a critical source of symbiotic gut bacteria, which appear to be protective against inflammation and obesity. Thus, we aim to perform a proof-of-concept, pilot RCT to assess the effectiveness of oral administration of maternal vaginal bacteria to restore the gut microbiota in CS-born babies. METHODS *Phase 1. To ensure that the gauze incubated in the maternal vagina contains vaginal bacteria, and to determine the viability of these bacteria. We will recruit 3 pregnant women aged 18 to 42 years, carrying singletons and scheduled for elective CS at 34 to 41 weeks of gestation. A sterile gauze will be inserted in the vagina for 30 minutes prior to CS. After removal, the gauze will undergo bacterial extraction using the QIAmp DNA extraction kit, and bacterial characterization by 16S amplicon sequencing. Phase 2 Aim - To determine whether babies receiving the maternal vaginal microbiota will have different gut microbiota profile compared to babies receiving placebo, with treated babies more closely resembling the bacterial profile of singletons vaginally-delivered. Participants - 30 women carrying singletons and scheduled for an elective CS; and 15 women carrying singletons born vaginally. Women will be aged greater than or equal to 18 years and will deliver at greater than or equal to 37 weeks of gestation. Procedures - 30 minutes before CS, a sterile gauze will be inserted into the maternal vagina, and kept in place for 30 minutes. After removal, the gauze will be placed in a sterile syringe with 5 ml of sterile water to obtain a vaginal-water supernatant, Soon after birth, some babies will receive 3ml of the vaginal-water supernatant orally, while others will receive placebo (3 ml of sterile water). The vaginally-born controls will not receive vaginal-water supernatant nor placebo. Infants will be assessed once within 24 hours of life, and subsequently at 1 month and 3 months of age (auxology and stools). Infant stool samples, as well as the remaining 2 ml of vaginal supernatant from CS-mothers will undergo whole metagenomic shotgun sequencing to assess gut microbiota composition and quantify strain transmission from mother to baby.