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Powdered human milk-derived versus bovine milk-derived breastmilk fortification: A multi-centre preterm randomised
Janet Berrington1,2, Mark Johnson3,4, Shalabh Garg5
1Newcastle Neonatal Services, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Insights
Powdered human milk-based fortifier (PHMF) did not reduce gut inflammation in preterm infants compared to powdered bovine milk-based fortifier (PBMF). However, infants receiving PHMF experienced slower weight gain, a finding of potential clinical significance.
Area of Science:
- Neonatal nutrition
- Gastroenterology
- Pediatric clinical trials
Background:
- Preterm infants require specialized nutrition for optimal growth and development.
- Human milk is the preferred nutrition source, often supplemented with fortifiers.
- Comparing human milk-based fortifier (PHMF) and bovine milk-based fortifier (PBMF) is crucial for understanding their impact on infant gut health and growth.
Purpose of the Study:
- To compare the effects of PHMF versus PBMF on gut inflammation, plasma amino acids, and clinical outcomes in preterm infants on an exclusive human milk diet.
- To assess faecal calprotectin levels as a marker of gut inflammation.
- To evaluate growth and neonatal morbidities in response to different fortifier types.
Main Methods:
- A randomized controlled trial involving preterm infants (<32 weeks gestation or <1500g) receiving exclusive human milk and full enteral feeds.
- Primary outcome: faecal calprotectin within 21 days of starting fortification.
- Secondary outcomes: calprotectin at discharge, plasma amino acids, growth, and neonatal morbidities.
Main Results:
- The trial was terminated early due to the withdrawal of PHMF.
- No significant differences in faecal calprotectin levels were observed between PHMF and PBMF groups at Day 7, Day 21, or up to discharge.
- Infants receiving PHMF exhibited slower weight gain compared to those receiving PBMF, reaching statistical significance at discharge.
Conclusions:
- PHMF did not demonstrate a reduction in gut inflammation, as indicated by faecal calprotectin levels, compared to PBMF.
- Slower weight gain in the PHMF group suggests a potential clinical concern requiring further investigation.
- The study highlights the importance of monitoring growth alongside gut health markers when using different fortifier types in preterm infants.
Objective:
To compare faecal calprotectin, plasma amino acids and clinical outcomes in preterm infants receiving powdered human milk-based fortifier (PHMF) compared to powdered bovine milk-based fortifier (PBMF) in preterm infants on an otherwise exclusive human milk diet.
Methods:
A randomised controlled trial in infants <32 weeks of gestation or <1500 g who only received human milk and had reached full enteral feeds (150 mL/kg/day), without pre-existing gastrointestinal morbidity. Primary outcome was faecal calprotectin within 21 days of starting fortification; secondary outcomes were calprotectin at discharge, plasma amino acids and clinical outcomes, including growth and neonatal morbidities.
Results:
The trial stopped early after the manufacturer's withdrawal of PHMF. Thirty-one infants were enroled, three without informative sampling, leaving 14 per group. No statistical differences were seen in faecal calprotectin on Day 7 (236 mcg/g PHMF vs. 303 mcg/g PBMF, p = 0.90) or 21 (135 mcg/g PHMF vs. 315 mcg/g PBMF, p = 0.21). Adjusting for gestation and day of life, and including all time points after enrolment to discharge, fortifier type did not impact faecal calprotectin (coefficient estimate -7.13, 95% confidence interval = -172 to 158, p = 0.93). Rates of key neonatal morbidities did not differ. PHMF infants grew more slowly reaching statistical significance in change in weight standard deviation score at discharge compared to PBMF infants (mean (standard deviation) -0.94 (0.7) PHMF vs. -0.24 (0.8) PBMF, p = 0.02).
Conclusions:
We did not detect reduced gut inflammation as measured by faecal calprotectin in PHMF compared to PBMF but weight gain was slower, of potential clinical importance.
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