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Published on: January 27, 2019
Maternal bacteria to correct abnormal gut microbiota in babies born by C-section
Éadaoin M Butler1,2, Valentina Chiavaroli2,3, José G B Derraik1,2,4,5
1A Better Start - National Science Challenge.
Insights
This pilot study investigates oral administration of maternal vaginal bacteria for cesarean-born infants. The goal is to establish healthy gut microbiota development and reduce risks of childhood diseases.
Area of Science:
- Microbiology
- Pediatrics
- Clinical Trials
Background:
- Cesarean section (CS) is linked to increased risks of childhood obesity, asthma, and celiac disease.
- Gut microbiota in CS-born infants differs from vaginally born infants, potentially due to reduced exposure to maternal vaginal bacteria.
- Vaginal seeding is an unproven method to normalize infant gut microbiota after CS.
Purpose of the Study:
- To assess the efficacy of oral administration of maternal vaginal bacteria for establishing normal gut microbiota in CS-born infants.
- To evaluate the degree of maternal strain transfer and overall effectiveness of this novel vaginal seeding method.
- To compare gut microbiota development in infants receiving active treatment versus placebo.
Main Methods:
- Pilot study of a single-blinded, randomized, placebo-controlled trial involving 30 CS-born infants.
- Infants randomized to receive either 3ml maternal vaginal bacteria supernatant or placebo (sterile water) orally.
- Whole metagenomic shotgun sequencing of stool samples at 1 month to analyze gut community structure; secondary outcomes assessed at 24 hours and 3 months.
Main Results:
- Primary outcome: differences in gut community structure between active treatment and placebo groups at 1 month.
- Secondary outcomes: overall gut community differences, similarity to vaginally born infants, maternal strain transfer, anthropometry, and body composition.
- Study aims to provide preliminary data on the safety and efficacy of oral vaginal seeding.
Conclusions:
- This study will provide initial evidence on the effectiveness of oral vaginal seeding for CS-born infants.
- Findings may inform future larger trials on mitigating long-term health risks associated with CS.
- The research explores a novel approach to support infant gut microbiome development.
Introduction:
There 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 Analysis:
Protocol 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 Dissemination:
Ethics 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.
Registration:
Australian New Zealand Clinical Trials Registry (ACTRN12618000339257).
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