Efficacy of an infant formula containing anti-Escherichia coli colostral antibodies from hyperimmunized cows in preventing diarrhea in infants and children: a field trial.

OBJECTIVE

To examine the efficacy of using oral bovine hyperimmune immunoglobulin concentrate with high-titer antibodies against Escherichia coli in preventing diarrhea caused by enteropathogenic E. coli.

DESIGN AND SETTING

This was a randomized, double-blind, controlled field trial conducted at the Al-Sheikh Omer Maternal and Child Health Center in Baghdad, Iraq from May to September 1998.

PARTICIPANTS

One hundred and twenty-five infants who satisfied the study criteria were included. One hundred and seven infants had adequate outcome data for the assessment of efficacy.

INTERVENTION

Infants were randomly assigned to receive either immunoglobulin concentrate-supplemented infant formula or non-supplemented control formula for 7 days. Groups were matched for physical characteristics at enrollment in the study. Another group, which was breastfed, was included to allow the collection of diarrhea morbidity data. Anthropometrics and diarrheal morbidity data were collected by weekly monitoring during the 6-month follow-up period.

RESULTS

The infants receiving supplemented formula had a lower incidence of diarrhea than the infants receiving control formula (P <0.05). Episodes of diarrhea were shorter in infants receiving supplemented formula (P <0.01). Moreover, infants receiving supplemented formula gained significantly more weight than control infants after 8 months of follow-up. The preparation was safe and well tolerated.

CONCLUSION

The results indicate that the reduction in morbidity associated with formula supplementation is of sufficient magnitude to be of public health significance. The use of these preparations provides an effective method for the prevention of diarrheal diseases.