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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?

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000968774
Acronym
BLOOM
Enrollment
105
Registered
2022-07-08
Start date
2022-08-19
Completion date
2024-04-18
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Sponsors

South Australian Health and Medical Research Institute
Lead SponsorOther Collaborative groups

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

- 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 criteria

- Contraindication to breastfeeding - Higher order pregnancies (triplet or more)

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 3, 2026