None listed
Conditions
Brief summary
The increase in allergic disease among children in the developed world is widely believed to be due to reductions in exposure to infective agents (the hygiene hypothesis). One way to counteract this is by exposing pregnant women to beneficial bacteria, such as probiotics. Using a randomized controlled double-blinded trial, we aim to investigate the effect of L rhamnosus HN001 taken daily (9X10^9 CFU) by pregnant women from the first trimester of pregnancy and during breast feeding until 6 months post-partum on the development of eczema and atopic sensitization in their infants at age 12 months. The effects of this probiotic on maternal health in pregnancy, including gestational diabetes mellitus, group B streptococcal vaginal infection and bacterial vaginosis will also be investigated as secondary outcomes. Probiotics are a cheap and safe intervention that may prevent cases of eczema and allergy in infancy and improve pregnancy outcomes for women.
Interventions
Lactobacillus rhamnosus HN001 administered daily as capsules to women from 14-16 weeks gestation till 6 months post birth while breastfeeding. The starting viable cell number is 6.1x1010 CFU* per gram, which equates to a dose per capsule of 9.2x109 CFU.
Sponsors
Dr Kristin Wickens
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A woman will be eligible if 1. either they or the unborn child’s biological father has a history of asthma or eczema treated by a doctor or allergic rhinitis treated by a doctor or pharmacist (but excluding alternative, herbal or homeopathic medicine). 2. she is 14 to 16 weeks gestation 3. she intends to breastfeed 4. she speaks English
Exclusion criteria
A woman will be ineligible if she 1. has a serious immunological disorder or is using immunomodulatory drugs 2. is currently using or intends to use probiotic drinks or supplements in themselves or in their child 3. is participating in another RCT 4. has known cardiac vavle disease for which antibiotic prophylaxis is required if undergoing dental procedures 5. required IVF to establish this pregnancy 6. has a pre-enrolment scan showing fetal abnormalities 7. does not agree to GP, midwife or hospital staff notification 8. has a severe allergy to cow's milk that requires her to carry adrenalin 9. has a history of transplant 10. has a history of HIV 11. is on continuous long-term antibiotics 12. does not intend to stay in Wellington or Auckland for the next 18 months 13. has miscarried since screening but prior to enrolment 14. is deemed unsuitable for study inclusion
Outcome results
None listed