A randomized placebo controlled trial of the effects of the probiotic Lactobacillus rhamnosus HN001 taken from the 1st trimester of pregnancy till 6 months post partum, if breastfeeding, on the development of eczema and atopic sensitization in infants by age 12 months.

Dr Kristin Wickens0 sites400 target enrollmentFebruary 15, 2012

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Dr Kristin Wickens

•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

•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