A maternal probiotic intervention for infant allergic disease preventio

Not Applicable

Completed

• Conditions: Eczema in infants; Atopic sensitization in infants; Gestational diabetes mellitus; Bacterial vaginosis during pregnancy; Group B strep during pregnancy; Skin - Dermatological conditions; Inflammatory and Immune System - Allergies; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12612000196842
• Lead Sponsor: Dr Kristin Wickens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
* Eczema defined according to the UK Working Party's Diagnostic Criteria for atopic dermatitis, which will be modified for use in infants. The criteria will be a history of scratching or rubbing plus 2 or more of the following occuring between birth and 1 year 1. a history of involvement of lower arms or legs 2. a history of a generally dry skin 3. visible eczema present on the cheeks or lower arms or legs with no axillary involvement - (to be assessed by study nurse at age 6 and 12 months)[Infant at age 6 and 12 months.];Atopic sensitization using skin prick tests to common environmental and food allergens[Infant at age 12 months];Eczema severity measured using SCORAD[Infant at age 6 and 12 months.]