Pregnancy Pregnancy and Childbirth
Conditions
Interventions
Eligible participants who provide written, informed consent and will be recruited into the study between 12- and 18-weeks’ gestation. The study statistician, who will not be involved in data collectio
Sponsors
University College Dublin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women less than 18 weeks’ gestation 2. Aged over 18 years and younger than 45 years old 3. BMI of 18.5-35 kg/m2 4. Singleton pregnancy 5. Participants must also be willing to stop taking any other probiotic supplements or probiotic-containing foods where applicable 6. Women must have sufficient understanding of the English language
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancy or fetal anomaly 2. A poor standard of English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune parameters (IL-10 after PBMC stimulation) measured using PBMC analysis at baseline and 28-32 weeks’ gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal inflammatory (TNF alpha and IL-6) and metabolic markers (HOMA, lipids) measured using venous blood samples at first visit (14-20 weeks) and second visit (28- 32 weeks gestation). 2. Stress/anxiety measured using Edinburgh Postnatal Depression Scale/Perceived Stress Scale/WHO well-being questionnaires at first visit (14-20 weeks), second visit (28- 32 weeks gestation) and postnatal visit (1-4 weeks postpartum) 3. Safety and tolerability of probiotic for the mother measured using questionnaires in late pregnancy and within 1 month postnatal 4. Pregnancy outcomes including gestational age, infant birthweight and infant length recorded from hospital records at birth 5. Transmission of probiotic from mother to baby stool measured using maternal and infant stool samples by strain-specific qPCR within 1 month postnatal | — |
Countries
Ireland
Outcome results
None listed