Articulo

INT J. IMMUNOTHERAPY XIX(1) 25-31 (2003)

BACTERIAL EXTRACT FOR THE PREVENTION OF RECURRENT URINARY TRACT INFECTIONS IN PREGNANT WOMEN: A PILOT STUDY BAERTSCHI R.,' BALMER J.A.,* EDUAH S.B.,3 LlECHTl A.," LURlE D.,5 SCHAMS H.6
1) Private practice, Yverdon, Switzerland. 2) Private practice, Spiez, Switzerland. 3 ) Private practice, Friburg, Switzerland. 4) Private practice, Huttwil,Switzerland. 5 ) Private practice, Liestal, Switzerland. 6) Private practice, Ilanz, Switzerland.

Summary: Recurrent urinary tract infections (UTls) are a frequent cause of concern during pregnancy, and there is a limited choice of appropriate antibiotic treatments. An alternative approach may be their prevention by an immunoactive bacterial extract that has already been shown to be safe and effectivein children and adults. Preclinical investigations have demonstrated the absence of embryotoxic or teratogenic effects. The aim of this open multicenter pilot study was to investigate the efficacy and safety of the bacterial extract OM-8930 in pregnant women with recurrent UTls. Sixty-two patients presenting with an acute UTI in weeks 16 to 28 of pregnancy were treated with one capsule daily ofOM-8930 until delivery. Antibiotics were given concomitantly for acute infection at entry and when necessaly. After ently, clinical checks were conducted I week after the end of initial antibiotic therapy and then every month until 6 weeks after delivery. The results show that the incidence of UTI recurrences was significantly reduced, with only 12 patients (19.4%) experiencing a recurrence duringthe study in comparison with 32 patients (52.5%)during the 6 months prior to the study (p = 0.002). The need for antibiotic therapy was also markedly reduced, with 34 patients (55.7%) requiring antibiotics before the study compared with eight (12.9%) during the study (p = 0.0002). Slight adverse events were observed in only two patients (nausea and heartburn). All newborns were healthy withnormal Apgar scores. This pilot study shows that OM-8930 reduces the incidence of UTI recurrences during pregnancy and is well tolerated. No negative effects in the newborns were observed.

Introduction
Urinary tract infections (UTls) are common in women and are among the most frequent infections
Address for correspondence: R. Baertschi, Rue du Pre 2, CH-1400 Yverdon, Switzerland.

seen ingeneral practice. Data from the USA indicate that UTls lead to approximately 8 million consultations per year resulting in 100,000 hospitalizations and a global annual cost of $1.6 billion (1). It is estimated that 20-30% of all women have one or more episodes of bacteriuria per year, of which 6%

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6lead to a UTI. Evidence in the literature suggests that 50% of young women experience a recurrence after 12 months, depending on the immunocompetence of the urogenital system (2). Around 80-85% of these UTls are caused by fscherichia coli (3). UTls are also the most frequent infections during pregnancy, with a prevalence of 5-1 0%. Preexisting asymptomatic bacteriuria, which outside ofpregnancy requires no treatment in the majority of cases, is often the trigger for a symptomatic UTI, which is also favored by the changes in the urinary tract that occur during pregnancy. Several studies indicate that during pregnancy untreated asymptomatic bacteriuria more frequently leads to acute pyelonephitis. Preterm birth, adverse effects on intrauterine growth, preeclampsia, hypertension andanemia may follow (4, 5). Early diagnosis and prompt treatment of UTls are important to prevent complications in the mother or fetus during pregnancy. For this reason, all pregnant women should undergo a routine urine test at the first consultation. To avoid risk to the fetus, the choice of antibiotic should be appropriate for the week of pregnancy and is therefore rather limited: ampicillins and...