None listed
Conditions
Brief summary
This project will recruit pregnant women to receive either a prebiotic supplement or a placebo supplement. They will be asked to take the supplement from 18-20 weeks gestation until their baby is 6 months of age. We will then examine whether supplementing the mother’s diet during pregnancy and breastfeeding with the prebiotic powder will reduce the development of allergies in her child. Both study groups will include children deemed to be at high risk of allergic disease (based on family allergy history).
Interventions
2 scoops of study powder containing 9g prebiotics (scGOS/IcFOS 9:1 ratio) will be mixed with food or beverage and consumed orally once daily by the participating pregnant women from study entry (18-20 weeks gestation) until 6 months of lactation. Compliance with the intervention will be assessed by questions asked at regular phone calls and appointment visits during the intervention period. The participating women will also be asked to return any unused study powder tins for reweighing as anothe
2 scoops of study powder containing 9g prebiotics (scGOS/IcFOS 9:1 ratio) will be mixed with food or beverage and consumed orally once daily by the participating pregnant women from study entry (18-20 weeks gestation) until 6 months of lactation. Compliance with the intervention will be assessed by questions asked at regular phone calls and appointment visits during the intervention period. The participating women will also be asked to return any unused study powder tins for reweighing as another measure of compliance at the end of the intervention period.
Sponsors
The Kids Research Institute Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Pregnant women less than 21 weeks of gestation, whose infants have a first-degree relative (mother, father or sibling) with a history of medically diagnosed allergic disease (asthma, allergic rhinitis, eczema and/or food allergy). Eligibility is not dependent on intent to breastfeed for a given length of time.
Exclusion criteria
Maternal smoking during pregnancy. Women already regularly consuming prebiotic supplement (more than twice a week). Current maternal diagnosis of lactose intolerance or cows milk allergy or other significant chronic gastrointestinal condition.
Outcome results
None listed