BASEL, SWITZERLAND—Immunostimulation with bacterial extracts has previously been shown to reduce infection rates in children, as well as in adults who are immunocompromised or who suffer from chronic respiratory inflammation or obstruction. A recent randomized placebo-controlled trial now demonstrates a multi-microbe extract’s ability to reduce the rate of recurrent upper respiratory tract infections (URTIs) in children.[1]

The extract, OM-85, includes lyophilized bacterial fractions of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, and Moraxella catarrhalis. Its efficacy is believed to result from stimulation of local and possibly systemic immune responses; administration results in elevated immunoglobulin levels, increased cytotoxic activity, and activation of macrophages, lymphocytes, and natural killer cells.

OM-85 has not yet been approved for use in the United States. Should the drug receive FDA approval, principal study author Urs B. Schaad, MD, recommended that it be given to “children with a history of frequent URTIs (ie, six or more such episodes in the previous year).” Administration should start “at the usual beginning of the URTI season (eg, in September or October),” said Dr. Schaad, Professor and Chairman of Pediatrics at University Children’s Hospital in Basel.

In a study supported by the Swiss pharmaceutical company OM Pharma, Dr. Schaad and colleagues enrolled 220 patients between the ages of 3 and 8 from 30 Swiss and 10 German centers. Each child had presented to his physician with an URTI and had had at least three URTIs during the previous 12 months.

One hundred twenty patients received one 3.5-mg capsule of the extract per day for the first month and then for 10 days each month during the third through fifth months. One hundred patients received placebo capsules. Patients were followed for six months after the start of treatment.

EXTRACT REDUCES INFECTION RATE

Whereas patients given placebo showed a seasonal increase in URTI incidence between September and November, followed by a plateau that began to diminish after February, those given OM-85 showed a fairly constant—and low—URTI rate throughout the year. Additionally, significantly fewer OM-85 recipients than patients receiving placebo (5.2% vs 9%) required prescriptions for local antiseptic, anti-inflammatory, antitussive, or mucolytic products. However, antibiotic use was similar between the two groups.

ANOVA confirmed a significantly lower rate of URTIs in OM-85 recipients than in those patients taking placebo during the five months of treatment. The cumulative difference between the two treatment groups was 0.42 URTIs per patient. Overall, OM-85 treatment lowered mean incidence of URTIs by 16%.

OM-85 was most effective in the children with the highest frequency of recurrent infections. For example, among the children who had had two to five URTIs in the previous year, OM-85 reduced the cumulative reinfection rate by only a nonsignificant 15% after five months of treatment. When children with six to 15 URTIs in the previous year were considered separately, though, the cumulative reinfection rate was 22% lower than in the placebo group.

—Mimi Zucker, PhD

Reference
1. Schaad UB, Mütterlein R, Goffin H. Immunostimulation with OM-85 in children with recurrent infections of the upper respiratory tract: a double-blind, placebo-controlled multicenter study. Chest. 2002:122:2042-2049.

Return to table of contents