Extrait

Background and study aims The healthy development and maturation of a newborn baby depends not only on the genetic information inherited from both parents, but also on the bacteria which come to live in their gut. These bacteria are collectively known as the microbiota and are passed mainly from mother to baby at the time of birth, and some additional bacteria come from the environment. This study will focus on a specific group of bacteria called bifidobacteria as these are the dominant bacteria in healthy infants’ guts and are associated with positive health outcomes. This study investigates whether a daily bifidobacterial probiotic capsule taken during pregnancy and breastfeeding results in transfer of these beneficial bacteria from mother to baby. This study also explores whether the probiotichas a beneficial effect on the mother’s blood sugars and lipid levels. Who can participate? Pregnant women with a body mass index (BMI) of ≥20kg/m2 and ≤35kg/m2, who are otherwise healthy What does the study involve? Participants are asked to avoid food and yoghurts that contain probiotics for the duration of the study. When they are 16 weeks pregnant they are asked to provide a stool sample, complete a 3-day food diary, provide blood samples, and have a skin swab, mouth swab/rinse and a vaginal swab. Participants are also offered a fetal ultrasound at this visit. They are then randomly allocated to receive either probiotic or placebo (dummy) capsules, which they take daily from 16 weeks of pregnancy until the baby is 3 months old. The research doctor/midwife meets them at regular antenatal appointments to ensure they have enough capsules and that they are having no difficulties. When they are 34 weeks pregnant participants are again asked to provide a stool sample, complete a 3-day food diary, provide blood samples, and have a skin swab, mouth swab/rinse and a vaginal swab. At this time participants have an additional growth scan of their baby. At the time the baby is born, a sample of blood is taken from the umbilical cord and a sample of the placenta and membranes (afterbirth) is taken if they deliver by elective caesarean section. Participants are also asked to take a sample of their baby’s first bowel movement, and to provide a small sample of breast milk and a swab from the skin of the breast. When the baby is 1 month old participants are asked to complete a 3-day food diary, provide stool samples (both mother and baby), and provide a sample of breast milk. This is repeated when the baby is 3 months old. What are the possible benefits and risks of participating? There are no health benefits from participating in the study but the knowledge gained may influence future medical care. There are no known risks associated with this study. Probiotics have been shown to be safe to take during pregnancy, with no risks for mother or baby. Participants may experience some discomfort in providing the requested samples but this will be brief and minimised as much as possible. Remembering to take the probiotic or placebo capsules each day may also be a minor inconvenience for participants. Where is the study run from? The National Maternity Hospital (Ireland) When is the study starting and how long is it expected to run for? December 2015 to December 2018 Who is funding the study? National Maternity Hospital Ireland Medical Fund Who is the main contact? Prof. Fionnuala McAuliffe

Critère d'inclusion

• Probiotics, pregnancy, Bifidobacteria, microbiome

Liens

• isrctn