College of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Flinders Drive, Bedford Park, SA, 5042, Australia.
Flinders Medical Centre, SA Pharmacy, SA Health, Bedford Park, SA, Australia.
Int Breastfeed J. 2024 Jun 20;19(1):43. doi: 10.1186/s13006-024-00650-z.
Many individuals who experience preterm birth struggle with early breast milk supply, which can translate into suboptimal longer-term breastfeeding outcomes. Further investigations into the potential role of early non-pharmacological and pharmacological interventions in improving breast milk production soon after birth is growing. While natural galactagogues, such as brewer's yeast, are widely perceived by women to be safer than pharmaceutical galactagogues and are taken by many women, evidence to support their efficacy is largely absent. The BLOOM study has been designed to determine the efficacy and safety of brewer's yeast and beta-glucans, derived from Saccharomyces cerevisiae, when administered soon after birth for increasing early breast milk supply in mothers who have delivered preterm.
The BLOOM study is a multicentre, double-blinded, randomised controlled trial that will assess if brewer's yeast or beta-glucan can increase early breast milk production following preterm birth. Target population are mothers of preterm infants born at less than 34 weeks' gestation who intend to provide breast milk for their infant, are less than 72 h following birth and able to give informed consent. Participants will be randomly allocated into three parallel groups at 1:1:1 ratio (n = 33 per group) to receive either brewer's yeast, beta-glucan or placebo capsules for seven days. The primary outcome is total expressed breast milk volume over a 24-hour period on day 7 of intervention. Participants and their infants will be followed until the infant reaches term corrected age or is discharged home from the neonatal unit (whichever occurs first).
The use of brewer's yeast as a galactagogue to enhance milk production is extremely common amongst breastfeeding mothers, however, there are no trials evaluating its efficacy and safety. This will be the first randomised controlled trial to 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. The trial will also evaluate whether early intervention with galactagogues soon after a preterm birth improves longer-term breastfeeding outcomes.
Australian and New Zealand Clinical Trials Registry ACTRN12622000968774 (registered on 8 July 2022) and UTN U1111-1278-8827.
许多经历早产的人都面临着早期母乳供应不足的问题，这可能会导致母乳喂养的长期效果不理想。因此，人们越来越关注早期非药物和药物干预措施在改善产后早期母乳产量方面的潜在作用。虽然天然催乳剂，如啤酒酵母，被许多女性认为比药物催乳剂更安全，而且很多女性都在服用，但支持其疗效的证据却很少。BLOOM 研究旨在确定啤酒酵母和β-葡聚糖（来源于酿酒酵母）在产后早期使用时，增加早产儿母亲早期母乳供应的疗效和安全性。
BLOOM 研究是一项多中心、双盲、随机对照试验，将评估啤酒酵母或β-葡聚糖是否能增加早产儿出生后早期的母乳产量。目标人群是妊娠 34 周以下分娩的早产儿的母亲，她们打算为婴儿提供母乳，产后不到 72 小时，并且能够知情同意。参与者将以 1:1:1 的比例随机分为三组（每组 33 人），在 7 天内分别接受啤酒酵母、β-葡聚糖或安慰剂胶囊。主要结局是干预第 7 天 24 小时内的总母乳量。参与者及其婴儿将被随访至婴儿达到校正胎龄足月或从新生儿病房出院（以先发生者为准）。
啤酒酵母作为一种催乳剂来增加产奶量在母乳喂养的母亲中非常常见，但是，没有试验评估其疗效和安全性。这将是第一个随机对照试验，评估两种常用的催乳剂——啤酒酵母和β-葡聚糖与安慰剂相比，在改善早产儿母亲产后母乳供应方面的疗效和安全性。该试验还将评估产后早期使用催乳剂是否能改善长期母乳喂养的结果。
澳大利亚和新西兰临床试验注册中心 ACTRN12622000968774（于 2022 年 7 月 8 日注册）和 UTN U1111-1278-8827。
