Research on donkey milk · Study 12

A human milk fortifier made from donkey milk

In Turin, Bertino et al. conducted a randomised study with 156 preterm infants. Their mother's milk was fortified either with a newly developed fortifier made from donkey milk or with a standard fortifier based on cow's milk. It is the original study of the FortiLat series.

Important: What was studied was a clinical specialty product for neonatology, not donkey milk for drinking. Donkey milk is not a substitute for breast milk or infant formula – the feeding of preterm infants belongs in medical hands.
Publication
Bertino et al.
2019 · JPGN
Study type
Randomised,
open-label study
Participants
156 preterm infants
(77 + 79)
Focus
Tolerability of the
human milk fortifier

What it's about

How well is the new fortifier tolerated?

Very small preterm infants need more protein and energy than breast milk alone provides. In hospital, their mother's milk is therefore enriched with a fortifier. Standard fortifiers are based on cow's milk.

Researchers at the University of Turin and the Italian National Research Council CNR developed a fortifier made from donkey milk: FortiLat. This study tested whether preterm infants tolerated it better than the standard fortifier. Both groups received a comparable energy and protein intake.

FortiLat was produced from donkey milk by membrane filtration, heat treatment and freeze-drying and was not commercially available at the time of the study.

What exactly was studied?

InterventionBreast milk with fortifier and protein concentrate from donkey milk
ComparisonBreast milk with cow's-milk-based fortifier and protein concentrate
MeasuredIntolerance, NEC, deaths, progression of feeding, growth
Not testedDonkey milk for drinking or pure donkey milk
Main resultFewer events, but no significant difference
SecondaryLess vomiting and fewer bilious gastric residuals

Briefly explained

The terms used in this study

ProductFortifier

An additive used to enrich breast milk for preterm infants with protein, energy and minerals.

EventIntolerance

Here: a pause in feeding of at least 8 hours, for example because of vomiting or gastric residuals.

DiseaseNEC

Necrotising enterocolitis – a serious bowel disease that mainly affects very small preterm infants.

StatisticsConfidence interval

The range in which the true effect plausibly lies. If it includes "no difference", the result is not significant.

Step 01Allocating

156 preterm infants were randomly assigned to one of the two fortifiers: 77 donkey milk, 79 cow's milk.

Step 02Fortifying

For 21 days, the breast milk was fortified with the respective fortifier and continuously adjusted.

Step 03Observing

Intolerance, NEC, deaths, progression of feeding and growth were recorded.

Step 04Follow-up

Follow-up studies later examined growth and development at 18 months and allergies at school age.

Interactive · The data at a glance

Four views of 156 preterm infants

How was allocation done, what did the primary endpoint show, what did the secondary analyses show – and where was there no difference? Switch between the views.

Donkey milk fortifier (77)Cow's milk fortifier (79)

Illustration of the values reported in the original publication with 95 % confidence intervals. The arrangement of the dots is schematic.

Key findings

What the researchers report

Primary endpoint

Fewer events – not significant

46 %relative risk reduction
0.100p-value
death, NEC or intolerance

With the donkey milk fortifier these events occurred less often. However, the wide confidence interval includes "no difference".

Secondary analyses

Less vomiting and fewer bilious gastric residuals

0.041p · vomiting
0.009p · bilious gastric residuals
repeated intolerance: HR 0.40

In the donkey milk fortifier group there were fewer such episodes per infant. As several endpoints were tested, these findings should be read with caution.

Feeding progression & growth

No difference

19 daysdonkey milk fortifier
19 dayscow's milk fortifier
until full feeding (median)

Growth until discharge also did not differ between the groups.

The study was open-label (the allocation was known), was run in a single centre, and in the control group considerably fewer events occurred (24 %) than assumed in the planning (45 %). According to the publication, several authors are inventors of a patent on the donkey milk fortifier.

Critical assessment

An indication, not proof

What the study shows

✓
A human milk fortifier made from donkey milk could be used in a randomised study in preterm infants.
✓
Fewer events occurred for the primary endpoint – without statistical significance.
✓
In secondary analyses there was less vomiting, fewer bilious gastric residuals and less repeated intolerance.
✓
Feeding progression and growth were comparable in both groups.

What it does not show

×
No proven superiority of the donkey milk fortifier.
×
No independent confirmation – one centre, open-label design, limited sample size.
×
No statement about pure donkey milk or donkey milk powder as a food.
×
No statement on the suitability of donkey milk for infants.

Research question for DON DONKEY’S®

What separates a clinical raw material from a food?

FortiLat shows that a standardised specialty product can be made from donkey milk. The underlying technology has been filed for a patent by the University of Turin and CNR (WO2015056166, EP3057450B1). For us, this is a reason to document the quality of our milk precisely – and to draw a clear line between food and clinical nutrition.

01 · COMPOSITIONRecord the protein profile and microbiological quality across several batches.
02 · PROCESSINGUnderstand what requirements filtration and drying place on the raw material.
03 · IP RIGHTSRespect existing patents and have them reviewed by experts.
04 · EXCHANGESeek discussions with research and clinical partners.

Original publication

A Novel Donkey Milk–derived Human Milk Fortifier in Feeding Preterm Infants: A Randomized Controlled Trial

Bertino E., Cavallarin L., Cresi F., Tonetto P., Peila C., Ansaldi G., Raia M., Varalda A., Giribaldi M., Conti A., Antoniazzi S., Moro G. E., Spada E., Milani S., Coscia A.
Journal of Pediatric Gastroenterology and Nutrition · 2019 · 68(1):116–123
Neonatology, University of Turin, CNR-ISPA, CREA, Italian Association of Human Milk Banks, University of Milan

DOI: 10.1097/MPG.0000000000002168
Full text: PMC6314716

The publication describes a study with a specialty product for preterm infants. It does not allow any statement about donkey milk or donkey milk powder as a food or any product-related statement for DON DONKEY’S®.

DON DONKEY’S® donkey milk

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100 % donkey milk · raw milk, frozen

On this page we report the findings of a published study. Independently of that, you will find our donkey milk here: 100 % donkey milk, frozen as raw milk.

Transparency: The study by Bertino et al. examined a clinical human milk fortifier, not DON DONKEY’S® donkey milk. Our donkey milk is a food and not infant food.
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Donkey Milk Powder

Donkey milk in powder form

For anyone who prefers a longer shelf life: our donkey milk in powder form – easy to store and portion.

Transparency: The study examined a clinical human milk fortifier, not our donkey milk powder. Our donkey milk powder is a food and not infant food.
€24,90

20g · Unit price: €1.245,00 / 1 kg · incl. VAT, plus shipping

View all sizes & purchase options →