None listed
Conditions
Brief summary
The primary aim of the project is to evaluate the effectiveness of oral probiotics for the prevention of mastitis in lactating women. Secondary aims will assess maternal breastfeeding outcomes, infant infections including gastroenteritis, and the acceptability of a novel mobile app. The primary hypothesis is that regular ingestion of probiotics by women in the first two months following birth will decrease the incidence of mastitis in lactating women. The secondary hypotheses are that exposure to probiotics may also confer a benefit to breastfeeding mothers and reduce risk of infection among infants, particularly gastroenteritis.
Interventions
The participant will be given an 8 week supply of the probiotic sachets containing Lactobacillus Fermentum (1x10^10 CFU/mL). Participants will be advised to take one sachet daily for a period of 8 weeks following the birth of her baby. The contents of the sachet should be mixed with water, juice or milk, stirred and consumed immediately. The number of unused sachets will be collected by the research coordinator at the end of the 8 week period.
Daily data on treatment intake, breast pain, inf
The participant will be given an 8 week supply of the probiotic sachets containing Lactobacillus Fermentum (1x10^10 CFU/mL). Participants will be advised to take one sachet daily for a period of 8 weeks following the birth of her baby. The contents of the sachet should be mixed with water, juice or milk, stirred and consumed immediately. The number of unused sachets will be collected by the research coordinator at the end of the 8 week period. Daily data on treatment intake, breast pain, infection symptoms and infant feeding will be collected by participants via the mobile phone application system (APP). Weekly questionnaires will collect data on maternal and infant well-being, unscheduled doctor’s visits, and medication intake. Women not using the mobile phone application system will receive a 2 month calendar diary to record her daily responses, along with a weekly questionnaire accessed by an emailed web-link. For all participants, follow-up questionnaires will be sent at 2, 6 and 12 months to collect secondary outcomes.
Sponsors
Perinatal Research Group, Kolling Institute, University of Sydney
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant women at least 18 years of age at 37 weeks gestation or later with a singleton pregnancy will be invited to participate in the trial. They will currently not be taking commercial probiotics containing lactobacillus fermentum; and will own a smartphone. Their intention at the time of consent will be to breastfeed their baby.
Exclusion criteria
Women with a history of Raynaud syndrome will not be eligible to participate in the trial. Any delivery/breast complication rendering the infant unable to breastfeed will be excluded. Women unable to speak/understand English will not be consented.
Outcome results
None listed