The BLOOM Study - can brewer's yeast or beta-glucan increase breast milk supply following preterm birth?
The BLOOM Study - can Brewer’s yeast or beta-gLucan increase mOther’s Own Milk supply following preterm birth?
South Australian Health and Medical Research Institute
99 participants
Aug 19, 2022
Interventional
Conditions
Summary
Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will evaluate the efficacy and safety of two commonly used galactagogues, Brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. Eligible women will be randomised to receive Brewer's yeast (1680 mg/day), Beta-glucan (250 mg/day) or placebo for 7 days, commencing within 72 hours of birth. The primary outcome will be assessed at day 7 following treatment initiation. All participants will undertake regular study assessments including at baseline (study enrolment), day 7 of treatment, postnatal day 21 and at infant discharge to home or term corrected (whichever comes first). Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will also undergo anthropometric assessment, and a breast milk, blood, urine, stool and buccal cell swab sample.
Eligibility
Inclusion Criteria6
- Infant born <34 weeks’ gestation (i.e. up to 33+6)
- Intention to provide breast milk
- Between 0 to 72 hours of birth
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Adequate English language skills
- Signed, written informed consent.
Exclusion Criteria2
- Contraindication to breastfeeding
- Higher order pregnancies (triplet or more)
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Interventions
Arm 1 - Brewer's Yeast, three 280 mg capsules administered orally twice a day (morning and evening), for a total daily dose of 1680 mg/day, intervention duration of seven days. Arm 2 - Beta-glucan, one 250 mg capsule administered orally once per day (morning), administered with two placebo capsules in the morning and three placebo capsules in the evening, intervention duration of seven days.
Locations(3)
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ACTRN12622000968774