Background Very preterm infants (< 32 weeks gestation) have a relatively high nutrient requirement for growth and development. The composition of human milk is often inadequate to ensure optimal growth so it is common to fortify human milk for very preterm infants with nutrient fortifiers based on bovine milk. However, there are concerns that bovine milk-based fortifiers may increase the risk of feeding intolerance, necrotizing enterocolitis and late-onset sepsis. We hypothesize that a bovine colostrum-based product is a suitable alternative to bovine milk-based products when used as a fortifier to human milk in very preterm infants. Methods/Design In an open-label multicentre randomised controlled pilot trial, 200 very preterm infants (26 + 0 to 30 + 6 weeks gestation at birth) will be randomly allocated to a bovine colostrum-based or a bovine milk-based fortifier added to mother’s own milk and/or human donor milk. Outcomes are growth rate, incidence of necrotizing enterocolitis and late-onset sepsis, a series of paraclinical endpoints, and practical feasibility of using the novel fortifier for very preterm infants. Discussion The optimal enteral diet and feeding regimen for very preterm infants remain debated; this clinical trial will document the feasibility, safety and preliminary efficacy of using bovine colostrum, rich in nutrients and bioactive factors, as a novel fortifier for human milk to very preterm infants . Data on infant growth, metabolism, gut function and immunity will be assessed from clinical data as well as blood and stool samples. Trial registration Registered retrospectively 25 May 2018 at ClinicalTrials.gov: NCT03537365 . Electronic supplementary material The online version of this article (10.1186/s13063-019-3367-7) contains supplementary material, which is available to authorized users.

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Background: Human milk does not meet the nutritional needs to support optimal growth of very preterm infants during the first weeks of life. Nutrient fortifiers are therefore added to human milk, though these products are suspected to increase gut dysmotility. The objective was to evaluate whether fortification with bovine colostrum (BC) improves bowel habits compared to a conventional fortifier (CF) in very preterm infants. Methods: In an unblinded, randomized study, 242 preterm infants (26–31 weeks of gestation) were randomized to receive BC (BC, Biofiber Damino, Gesten, Denmark) or CF (FM85 PreNAN, Nestlé, Vevey, Switzerland) as a fortifier. Stools (Amsterdam Stool Scale), bowel gas restlessness, stomach appearance score, volume, and frequency of gastric residuals were recorded before each meal until 35 weeks post-menstrual age. Results: As intake of fortifiers increased, stools became harder in both groups (p < 0.01) though less in BC infants (p < 0.05). The incidence of bowel gas restlessness increased with laxative treatments and days of fortification in both groups (p < 0.01), but laxatives were prescribed later in BC infants (p < 0.01). With advancing age, stomach appearance scores improved, but more so in BC infants (p < 0.01). Conclusions: Although there are limitations, a minimally processed, bioactive milk product such as BC induced similar or slightly improved bowel habits in preterm infants.