Probiotics, pregnancy, Bifidobacteria, microbiome Pregnancy and Childbirth
Conditions
Interventions
Eligible participants will be recruited from the outpatients’ department of the hospital at approx. 12 weeks’ gestation. Once a patient has given written informed consent to participate in the trial,
Sponsors
University College Dublin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participant inclusion criteria as of 14/11/2018: 1. Pregnant women over the age of 18 years, capable of giving informed consent 2. With adequate understanding of the English language and an understanding of the study to enable them to give informed consent to participate 3. With a Body Mass Index of =18.5 kg/m2 and =35 kg/m2 Previous participant inclusion criteria: 1. Pregnant women over the age of 18, capable of giving informed consent 2. With adequate understanding of the English language and an understanding of the study to enable them to give informed consent to participate 3. With a Body Mass Index of =20kg/m2 and =35kg/m2
Exclusion criteria
Exclusion criteria: 1. A history of gestational diabetes in a previous pregnancy 2. Pre-gestational diabetes e.g. Type 1 or Type 2 diabetes 3. A multiple pregnancy or fetal anomaly 5. A poor standard of English 6. A previous perinatal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of the supplemented bifidobacterial strain in the infant’s stool in the 1st week postpartum, at 1 month postpartum and at 3 months postpartum. To measure this the infant stool will be analysed for the presence of the supplemented bifidobacterial strain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the following between the probiotic and placebo groups: 1. Maternal lipids 2. Maternal insulin resistance as measured by fasting glucose and HOMA-IR 3. Maternal C Reactive Peptide Maternal bloods will be taken in early (approx. 16 weeks gestation) and late (approx. 34 weeks gestation) pregnancy and will be analysed for these metabolic parameters | — |
Countries
Ireland
Contacts
Public ContactFionnuala McAuliffe
Outcome results
None listed