Milk introduction before the age of 6 months and the risk of milk allergy
Näytönastekatsaukset
Aleksi Raudasoja
9.6.2025
Milk introduction before 6 months of age may have little or no effect on the risk
of milk allergy, but the evidence is very uncertain.
Due to low evidence certainty, it is difficult to estimate potential absolute benefits
from early milk introduction. In a systematic review of early food introduction, half
of the trials compared cow's milk formulas to milk-free formulas. By excluding the
formula trials, pooled event rates were 6/1575 in the intervention group and 13/1602
in the control group, suggesting a small benefit, but event rates are very small
«Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing ...»1. A meta-analysis of 11 studies suggested a small to no impact on study withdrawals,
RR 1.05 (95% CI 0.61-1.82) «Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing ...»1.
Table 1. Description of the included studies
| Reference |
Study type |
Population |
Intervention and comparison |
Outcomes |
Risk of bias |
| SR=systematic review; MA=meta-analysis |
|
«Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing ...»1 |
SR and MA |
Infants 3-6 months old. Both low and high risk populations. |
Early milk introduction vs placebo, milk-free formula or no intervention (in control
group milk was introduced at 8 months or later) |
Milk allergy: double-blind, placebo-controlled food challenge; open food challenge;
medical diagnosis at 6-36 months. |
moderate |
Table 2. Additional comments for included studies
| Reference |
Comments |
|
«Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing ...»1 |
Of six trials, three compared milk formula vs milk-free formula. The remaining trials
compare early cow's milk introduction at age of 3-4 months to introducing milk at
six months of age (2 trials) or at 8 months (1 trial). One of the six trials had placebo
control. Of the six trials, two were considered to be at low risk of bias by the review
authors. |
Results
Table 3. Cow milk allergy – confirmed by food challenge
| Reference |
Number of studies and number of patients (I/C) |
Follow-up time |
Absolute number of events (%) I |
Absolute number of events (%) C |
Relative risk (95% CI) |
| I= intervention; C=comparison; CI=confidence interval |
|
«Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing ...»1 |
6 |
6-36 months |
25/1944 |
25/1956 |
0.84 (0.38-1.87) |
Level of evidence: very low
The level of evidence was rated down for risk of bias, indirectness, and imprecision.
|
References
- Scarpone R, Kimkool P, Ierodiakonou D, ym. Timing of Allergenic Food Introduction
and Risk of Immunoglobulin E-Mediated Food Allergy: A Systematic Review and Meta-analysis.
JAMA Pediatr 2023;177(5):489-497 «PMID: 36972063»PubMed
Article ID: nak09994 (050.026)
© 2025 The Finnish Medical Society Duodecim
