Evaluation of Faecal microbiota following PRobiotics in Infants of Mothers with Diabetes (PRIMD) trial: a double-blind placebo-controlled pilot randomized trial
Not Applicable
- Conditions
- Infants of mothers with gestational diabetesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonMetabolic and Endocrine - DiabetesReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12624000930583
- Lead Sponsor
- King Edward Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
gestation>35 weeks at birth
Infant of mother with gestational diabetes mellitus
predominantly breast feeding and intending to breast feed in future
resident of Perth metropolitan area
informed parental consent
Exclusion Criteria
Resident outside Perth metropolitan area
presence of maternal chorioamnionitis or prolonged rupture of membranes (>18 hours)
babies needing antibiotics at birth
mothers who have received antibiotics within 7 days prior to delivery
congenital malformations
chromosomal aberrations
not ready for feeds due to any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method