• Éadaoin M Butler, Valentina Chiavaroli, Derraik José G B JGB, Celia P Grigg, Brooke C Wilson, Nicholas Walker, Justin M OʼSullivan, and Wayne S Cutfield.
• aA Better Start - National Science Challenge bLiggins Institute, University of Auckland, Auckland, New Zealand cNeonatal Intensive Care Unit, Pescara Public Hospital, Pescara, Italy dDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden eEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China fDepartment of Obstetrics and Gynaecology, Auckland City Hospital, Auckland District Health Board, New Zealand.
• Medicine (Baltimore). 2020 Jul 24; 99 (30): e21315.

IntroductionThere is evidence that caesarean section (CS) is associated with increased risk of childhood obesity, asthma, and coeliac disease. The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth. Vaginal seeding is a currently unproven practice intended to reduce such differences, so that the gut microbiota of CS-born babies is similar to that of babies born vaginally. Our pilot study, which uses oral administration as a novel form of vaginal seeding, will assess the degree of maternal strain transfer and overall efficacy of the procedure for establishing normal gut microbiota development.Methods And AnalysisProtocol for a single-blinded, randomized, placebo-controlled pilot study of a previously untested method of vaginal seeding (oral administration) in 30 CS-born babies. A sample of maternal vaginal bacteria is obtained prior to CS, and mixed with 5 ml sterile water to obtain a supernatant. Healthy babies are randomized at 1:1 to receive active treatment (3 ml supernatant) or placebo (3 ml sterile water). A reference group of 15 non-randomized vaginal-born babies are also being recruited. Babies' stool samples will undergo whole metagenomic shotgun sequencing to identify potential differences in community structure between CS babies receiving active treatment compared to those receiving placebo at age 1 month (primary outcome). Secondary outcomes include differences in overall gut community between CS groups (24 hours, 3 months); similarity of CS-seeded and placebo gut profiles to vaginally-born babies (24 hours, 1 and 3 months); degree of maternal vaginal strain transfer in CS-born babies (24 hours, 1 and 3 months); anthropometry (1 and 3 months) and body composition (3 months).Ethics And DisseminationEthics approval by the Northern A Health and Disability Ethics Committee (18/NTA/49). Results will be published in peer-reviewed journals and presented at international conferences.RegistrationAustralian New Zealand Clinical Trials Registry (ACTRN12618000339257).

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