Latar belakang: Infeksi saluran napas akut (ISPA) merupakan salah satu penyakit yang mempunyai angka mortalitas dan morbiditas yang besar di dunia maupun di Indonesia. Kejadian ISPA pada balita biasanya berulang merupakan sumber masalah karena mempengaruhi fungsi paru secara negatif dan merupakan sumber penggunaan antibiotik tersering. Diperlukan suatu strategi untuk mengurangi angka kejadian ISPA berulang pada balita. Imunostimulan OM-85 BV telah banyak diteliti manfaatnya dalam mengurangi beban penyakit ISPA pada dewasa dan anak. Sampai saat ini belum ada penelitian mengenai peran penggunaan imunostimulan OM-85 BV untuk mengurangi angka kejadian ISPA pada balita di Indonesia. Tujuan: Mengetahui pengaruh pemberian OM-85 BV terhadap angka kejadian ISPA dan kadar serum imunoglobulin A (IgA). Metode: Studi uji klinis kuasi eksperimental di RS Cipto Mangunkusumo, dari Februari hingga November 2018, melibatkan 35 balita dengan riwayat ISPA berulang. Subjek diberikan OM-85 BV selama tiga bulan (10 hari per bulan). Pencatatan frekuensi ISPA dan rerata lama sakit dilakukan secara retrospektif sebelum terapi, dan secara prospektif selama enam bulan setelah terapi. Dilakukan juga pemeriksaan usap tenggorok dan kadar serum IgA sebelum dan sesudah terapi OM-85 BV. Hasil: Pemberian OM-85 BV mengurangi angka kejadian ISPA pada balita sebanyak dua episode dalam enam bulan (p <0,05) dan mengurangi rerata lama sakit sebanyak satu hari (p <0,05). Terdapat peningkatan kadar serum IgA setelah pemberian OM-85 BV, namun tidak signifikan secara statistik (p =0,062). Simpulan: Pemberian OM-85 BV dapat mengurangi angka kejadian ISPA dan rerata lama sakit pada balita, namun tidak meningkatkan kadar serum IgA secara bermakna.

---

Background: Acute respiratory tract infection (ARTI) is a disease with high mortality and morbidity in the world and in Indonesia. In children under five, ARTI is usually recurrent. It affects lung function negatively and is a source of frequent antibiotics use. A strategy is needed to reduce the incidence of recurrent ARTI in children under five years old. OM-85 BV is an immunostimulant that has been numerously studied in an effort to reduce the burden of ARTI in adults and children. Until now there has been no research using OM-85 BV evaluating its effect in reducing ARTI incidence in Indonesian children age five years and under.

Objective: Investigating the effect of OM-85 BV on the incidence of ARTI and serum level of immunoglobulin A (IgA) in children under five years old.

Methods: A quasi-experimental clinical trial was done at Cipto Mangunkusumo Hospital, from February to November 2018, involving 35 children under five with history of recurrent ARTI. Subjects were given OM-85 BV for three months (10 days per month). The frequency of ARTI and average duration of illness was recorded retrospectively before therapy, and prospectively for six months after therapy. Throat swabs culture and serum IgA level were measured before and after OM-85 BV therapy.

Results: The administration of OM-85 BV reduced the frequency of ARTI in subjects by two episodes in six months (p <0.05) and reduced the average duration of illness by one day (p <0.05). There was an increase in serum IgA level after OM-85 BV administration, but not statistically significant (p = 0.062).

Conclusion: Administration of OM-85 BV reduced the frequency of ARTI and decreased average duration of illness in children under five, but did not significantly increase serum IgA level.