The Effect of a Probiotic Containing Lacticaseibacillus rhamnosus and Bifidobacterium longum subsp. infantis on Clinical Outcomes in Children Aged 2–10 Years with Recurrent Upper Respiratory Tract Infections: A Multicenter Cohort Study

Abstract

ABSTRACT Aim: To evaluate the effects of a probiotic combination containing Lacticaseibacillus rhamnosus GG and Bifidobacterium longum subsp. infantis on the frequency of upper respiratory tract infections (URTI), antibiotic use, school absenteeism, and gastrointestinal microbiota parameters in children aged 2–10 years with recurrent URTI. Materials and Methods: This retrospective, observational, controlled, multicenter cohort study was conducted across nine pediatric outpatient clinics in Türkiye. The study enrolled 200 children aged 2–10 years with a history of at least three URTI episodes in the preceding six months. Children were assigned to two groups: Group 1 (n=100) received a daily six-drop Lacticaseibacillus rhamnosus GG + Bifidobacterium longum subsp. infantis probiotic combination in addition to standard care; Group 2 (n=100) received standard care alone. Clinical parameters were assessed at baseline (V0), month 3 (V1), and month 6 (V2). Mann-Whitney U and chi-square tests were used for between-group comparisons; Wilcoxon signed-rank test was applied for within-group longitudinal analysis. Results: In Group 1, the mean number of URTI episodes decreased from 4.05±0.95 at V0 to 1.39±1.04 at V2 (p<0.001; 65.7% reduction), whereas no significant change was observed in the control group (2.06→2.09; p=0.592). Antibiotic use declined by 58.7%, school absenteeism by 70.9%, and febrile days by 55.5% in Group 1 (all p<0.001). More pronounced clinical improvement was observed in subgroups of children born by cesarean section, those who received no breast milk, and those with a history of frequent antibiotic exposure. Product adherence was 97.5±4.4% and no adverse events were reported. Conclusion: The Lacticaseibacillus rhamnosus GG + Bifidobacterium longum subsp. infantis probiotic combination significantly reduces both infection burden and antibiotic use in children with recurrent URTI, with particularly marked clinical efficacy in cesarean-born children, those with minimal breast milk exposure, and those with high prior antibiotic use.

Keywords

• probiotics
• upper respiratory tract infection
• Lacticaseibacillus rhamnosus
• Bifidobacterium longum subsp. infantis
• child

Supporting Institution

None

Ethical Statement

The study was approved by the İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital Scientific Research Ethics Committee on June 15, 2026, with decision number 274. The study was conducted in accordance with the Declaration of Helsinki. Since this was a retrospective observational study using anonymized archive data, the requirement for informed consent was waived.

Thanks

The authors would like to thank all participating centers and healthcare professionals who contributed to the data collection process.

Tekrarlayan Üst Solunum Yolu Enfeksiyonu Olan 2-10 yaş Çocuklarda Lacticaseibacillus rhamnosus ve Bifidobacterium longum subsp. İnfantis İçeren Probiyotik Kullanımının Klinik Sonuçlar Üzerine Etkisi: Çok Merkezli Kohort Çalışması

Abstract

ÖZET Amaç: Tekrarlayan üst solunum yolu enfeksiyonu (ÜSYE) öyküsü olan 2-10 yaş arası çocuklarda Lacticaseibacillus rhamnosus GG ve Bifidobacterium longum subsp. infantis içeren probiyotik kombinasyonunun ÜSYE atak sıklığı, antibiyotik kullanımı, okul devamsızlığı ve gastrointestinal mikrobiyota parametreleri üzerine etkisini değerlendirmektir. Gereç ve Yöntem: Bu retrospektif, gözlemsel, kontrol gruplu, çok merkezli kohort çalışması dokuz farklı çocuk sağlığı ve hastalıkları kliniğinde yürütüldü. Çalışmaya son altı ayda en az üç ÜSYE atağı geçirmiş, 2–10 yaş arasında 200 çocuk dahil edildi. Çocuklar iki gruba ayrıldı: Grup 1 (n=100) standart takibe ek olarak günde altı damla Lacticaseibacillus rhamnosus GG + Bifidobacterium longum subsp. infantis probiotik içeren probiyotik kombinasyonu aldı; Grup 2 (n=100) yalnızca standart takip ile izlendi. Başlangıç (V0), 3. ay (V1) ve 6. ay (V2) vizitlerinde klinik parametreler değerlendirildi. Gruplar arası karşılaştırmada Mann-Whitney U ve ki-kare testleri, grup içi zamana bağlı değişim analizinde Wilcoxon işaret-sırası testi kullanıldı. Bulgular: Grup 1'de ÜSYE atak sayısı V0'da 4,05±0,95 iken V2'de 1,39±1,04'e geriledi (p<0,001; %65,7 azalma). Kontrol grubunda anlamlı değişim gözlenmedi (2,06→2,09; p=0,592). Grup 1'de antibiyotik kullanım sıklığı %58,7, okul devamsızlığı %70,9 ve ateşli gün sayısı %55,5 oranında azaldı (tüm p<0,001). Sezaryen ile doğan çocuklarda, hiç anne sütü almayanlarda ve yoğun antibiyotik kullananlardan oluşan alt gruplarda daha belirgin klinik iyileşme saptandı. Ürün kullanım uyumluluğu %97,5±4,4 olup hiçbir çocukta yan etki bildirilmedi. Sonuç: Lacticaseibacillus rhamnosus GG + Bifidobacterium longum subsp. infantis probiotik içeren probiyotik kombinasyonu, tekrarlayan ÜSYE geçiren çocuklarda hem enfeksiyon yükünü hem de antibiyotik kullanımını anlamlı ölçüde azaltmakta; özellikle sezaryen doğan, az anne sütü alan ve çok antibiyotik maruziyeti yaşayan çocuklarda belirgin klinik etkinlik sergilemektedir.

Keywords

• probiyotik
• üst solunum yolu enfeksiyonu
• Lacticaseibacillus rhamnosus
• Bifidobacterium longum subsp. infantis
• çocuk

Supporting Institution

Yok

Ethical Statement

Çalışma, İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi Bilimsel Araştırmalar Etik Kurulu tarafından 15 Haziran 2026 tarihinde, 274 karar numarası ile onaylanmıştır. Çalışma, Helsinki Bildirgesi ilkelerine uygun olarak yürütülmüştür. Retrospektif gözlemsel tasarımda ve anonimleştirilmiş arşiv verileri kullanılarak yürütülen bir çalışma olması nedeniyle bilgilendirilmiş onam gerekliliğinden muaf tutulmuştur.

Thanks

Yazarlar, veri toplama sürecine katkıda bulunan tüm katılımcı merkezlere ve sağlık çalışanlarına teşekkür eder.

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