Donkey Milk Study: Tolerability in Cow’s Milk Allergy (Tesse 2009)

Contents

1. Study summary
2. Study methodology
3. Key figures
4. Results
5. Critical assessment
6. Funding, conflicts of interest, and level of evidence
7. Our assessment

25 children with confirmed cow's milk allergy, tested under medical supervision: 24 (96%) tolerated donkey milk in an open provocation test; follow-up over 4–6 months.

Study summary

Feature	Information
Original title	Adequacy and tolerance to ass's milk in an Italian cohort of children with cow's milk allergy
Authors	Tesse R., Paglialunga C., Braccio S. et al.
Journal	Italian Journal of Pediatrics, Volume 35, Article 19
Year	2009
Country	Italy (Department of Biomedicine of the Developmental Age, Pediatric Clinic "S. Maggiore", University of Bari, Bari, Italy)
Study type	Human study
DOI	10.1186/1824-7288-35-19

Study methodology

Prospective observational study conducted at the University of Bari's pediatric allergy clinic: Between January and July 2008, 30 children (aged 6 months to 11 years) suspected of cow's milk protein allergy were enrolled. The diagnosis was confirmed after a 4-week elimination diet using a double-blind, placebo-controlled food challenge (DBPCFC) with cow's milk; skin prick tests and specific serum IgE were also performed. Children with confirmed allergy subsequently received fresh donkey milk in an open provocation test at the clinic equipped with emergency facilities. If tolerated, donkey milk was incorporated into an age-appropriate balanced diet; weight, height, BMI, and blood values were measured at baseline (T0) and after 4–6 months (T1). There was no control group.

Key figures

Value	Meaning
30	children suspected of cow's milk protein allergy were enrolled (January–July 2008)
4.5 years	Median age (range according to Table 6 months to 10 years, according to Abstract up to 11 years)
28	children with cow's milk allergy confirmed by DBPCFC
25	children tested with donkey milk (3 families declined continuation)
24 out of 25 (96%)	children who tolerated donkey milk in the open provocation test (22 IgE-mediated, 2 non-IgE-mediated)
1	child with a systemic reaction to donkey milk (skin changes, cough, vomiting); tested positive in the prick test and for specific IgE to donkey milk
27 (90%)	children with an IgE-mediated form of cow's milk allergy
2	children with a positive skin prick test or positive specific IgE to donkey milk at the start of the study

Results

Cow's milk allergy was confirmed by double-blind, placebo-controlled provocation in 28 out of 30 enrolled children. 27 children (90%) had an IgE-mediated form, while 2 children (7%) with gastrointestinal symptoms had a non-IgE-mediated form.

25 children were tested with fresh donkey milk under medical supervision in an open provocation test. 24 of them (96%) tolerated it – 22 with IgE-mediated and 2 with non-IgE-mediated allergy.

One child had a systemic reaction with skin changes, cough, and vomiting. This was the only tested child with a positive skin prick test and elevated specific IgE against donkey milk; the authors consider this an indication of the predictive value of these tests.

Children with severe reactions to cow's milk did not continue to participate. The authors therefore expressly limit their results to mild to moderate forms of cow's milk allergy.

After 4–6 months, the mean weight increased from 17.3 to 19.4 kg (p = 0.02) and the mean height from 100.3 to 105.4 cm (p < 0.001). The BMI remained unchanged at the 50th percentile, with values of 16.1 and 16.0, respectively.

According to the authors, blood values (including iron, calcium, proteins, cholesterol, triglycerides, glucose, and folic acid) showed no relevant changes; the data are not shown. Tests for occult blood in the stool were negative.

All children were older than 6 months and did not rely exclusively on milk. According to the study, all enrolled children accepted the taste and did not withdraw from the study.

Critical assessment

• Strength – Gold-standard diagnostics: Cow's milk allergy was confirmed by double-blind, placebo-controlled provocation; all provocations took place in the clinic equipped with emergency facilities.
• Limitation – Small sample size: Only 25 children were tested with donkey milk; the donkey milk test was open (not blinded), and there was no control group.
• Limitation – Only mild cases: Children with severe reactions to cow's milk were excluded. The results apply only to mild to moderate forms in this group and do not replace medical assessment.
• Note – Growth without comparison: Weight and height increases over 4–6 months are to be expected in children; without a control group, no effect of donkey milk can be inferred. The blood values are not reported in detail.
• Note – Inconsistencies in the text: Neurodermatitis is stated as "24/20" (presumably 24/30); 27 IgE-mediated plus 2 non-IgE-mediated cases result in 29 instead of 30; the age range according to the Abstract is up to 11 years, while according to the Table it is up to 10 years. The standard deviations for height are larger in boys and girls than in the overall group.
• Note – Supplementary nutrition: Donkey milk was part of a varied, age-appropriate balanced diet in children over 6 months; the statements do not refer to donkey milk as the sole source of nutrition.

Funding, conflicts of interest, and level of evidence

The authors state that there are no competing interests.

Level of evidence: Small, uncontrolled human observational study – low level of evidence, no generalizable statements.

Our assessment

Small, uncontrolled clinical observational study in children with medically confirmed cow's milk allergy under medical supervision; the results apply only to this group. Donkey milk is not a substitute for medical advice – in cases of allergy, diet should always be coordinated with a doctor.

Open research question: How frequently do cross-reactions between cow's milk and donkey milk proteins occur in larger, controlled studies, and what role do the prick test and specific IgE to donkey milk play in prediction?

Summarized and reviewed by the DON DONKEY'S editorial team based on the original publication · As of: October 2026. This summary does not replace the original work.

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End of study summary. The study was conducted independently by DON DONKEY'S® and does not refer to our products. Our donkey milk is a food.