Australian Clinical Trials

Broad Health Condition Inflammatory and Immune System
Oral and Gastrointestinal

Specific Health ConditionAllergies
Normal oral and gastrointestinal development and function

Trial FocusPrevention

Recruitment Details

Recruitment status
Active, not recruiting

Recruitment State
WA

Hospital
Joondalup Health Campus - Joondalup

Postcode
6027 - Joondalup

Anticipated date of first participant enrolment27/05/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial 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).

Key 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.

Minimum age18 Years

Maximum age50 Years

GenderFemales

Can Healthy volunteers participate? Yes

Key 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.