Türkiye’de akut ishalli çocuklarda Lactobacillus rhamnosus LGG ve Bifidobacterium animalis subspecies lactis BB-12 kombinasyonunun ishal ve hastanede yatış süresi üzerine etkisi

Öz

Amaç Akut ishal tüm dünyada en önemli morbidite ve mortalite nedenleri arasında yer almaktadır. İshal nedeni ile başvuran tüm hastalarda, dehidratasyonun temel tedavisi oral rehidratasyon sıvısıdır. Probiyotikler, akut ishal destek tedavi seçenekleri arasında yer almaktadır. Bu çalışmanın amacı akut ishali olan çocuklarda Lactobacillus rhamnosus GG (LGG) ve Bifidobacterium animalis subspecies lactis BB-12 (BB-12) kombinasyonun ishal süresi ve hastanede yatış süresi üzerine etkisinin değerlendirilmesidir.

Yöntem Bu çok merkezli, randomize (240 çocuk, probiyotik ile kontrol 2:1 randomizasyon), tek kör çalışma, akut ishal yakınmalarının başlamasından 24-72 saat içerisinde hastaneye başvuran, yaşları 6 ay ile 60 ay arasında değişen çocuklarda yapıldı. Çalışmaya hafif ve orta derecede dehidratasyonu olan çocuklar dahil edildi. Çalışmaya dahil edilen çocuklarda, kontrol grubu standart tedavi alırken, probiyotik grubu 5 gün süre ile LGG ve BB-12 (her bir probiyotik 1×109 koloni) kombinasyonu aldı. Çalışmanın primer sonlanım noktası olarak ishal süresinin Bristol gayta skoru ile takip edilmesi planlandı. Sekonder sonlanım noktası ise hastanede yatış süresi (gün) ve 72. saatin sonunda ishal tablosu gerileyen çocuk yüzdesi olarak belirlendi.

Bulgular Çalışmaya katılan 240 çocuğun 218’nin (probiyotik grubunda 150 çocuk, kontrol grubunda 68 çocuk) verileri değerlendirildi. LGG ve BB-12 grubunda ishal süresinin kontrol grubuna göre anlamlı derecede düşük olduğu saptandı (sırası ile 74.5 ± 40.8 saat, 98.4 ± 22.9 saat, P<0.001). Çalışmanın 72.saatinde ishal tablosu gerileyen çocuk yüzdesi LGG ve BB-12 grubunda kontrol grubuna göre belirgin yüksek olduğu saptandı (%60 vs. %33.8, P<0.001). Ortalama hastanede yatış süresi gruplar arasında benzer olarak bulundu (5.03 ± 2.3 gün vs. 5.25 ± 1.3 gün, P>0.05).

Sonuç LGG ve BB-12 kombinasyonun akut ishal olgularında ilk kez değerlendirildiği bu çalışmada,ishal süresi üzerine olumlu etkilerinin olduğu gösterildi. Hastaneye yatan çocuklarda ishal süresinin yaklaşık 24 saat kısaldığı saptandı. Hastaneye yatan çocuklara ek olarak, akut ishal nedeni ile poliklinik başvurusu yapan çocuklarda yapılacak randomize klinik çalışmalar ile bu kombinasyonun etkisi daha detaylı değerlendirilmelidir.

Anahtar Kelimeler

• probiyotik
• LGG
• BB-12
• ishal
• hastaneye yatış
• gastroenterit
• Lactobacillus rhamnosus
• Lacticaseibacillus rhamnosus

Effect of Lactobacillus rhamnosus LGG and Bifidobacterium animalis subspecies lactis BB-12 combination on the duration of diarrhea and length of hospital stay in children with acute diarrhea in Turkey

Öz

Background Acute diarrhea continues to be a leading cause of morbidity and mortality worldwide. The main therapy for all individuals with dehydration caused by diarrhea is oral rehydration. Probiotics have been proposed as a complementary therapy in the treatment of acute diarrhea. We aim to evaluate the effect of a combination of Lactobacillus rhamnosus GG (LGG) with Bifidobacterium animalis subspecies lactis BB-12 (BB-12) on the duration of diarrhea and length of hospital stay in children with acute diarrhea.

Methods A multicenter, randomized (240 children, 2:1 randomized for probiotic vs. control), single blind, hospital based clinical trial was performed in children (6 to 60 months) with acute watery diarrhea lasting more than 24 but less than 72 hours, requiring hospitalization. We enrolled children with clinical signs of mild to moderate dehydration. The children received conventional therapy with or without the combination of LGG and BB-12 (1 × 109 colony forming units for each) for 5 days. The primary endpoint was the duration of diarrhea (in hours), defined as the first normal stool according to the Bristol stool score (score < 5). Secondary outcome measures were duration of hospitalization (days) and percentage of children without diarrhea at 72 hours of intervention.

Results In total, data from 218 of 240 children could be evaluated (150 in the probiotic group and 68 in the control group). The duration of diarrhea was significantly reduced in the LGG and BB-12 group compared to the control group (74.5 ± 40.8 hours vs. 98.4 ± 22.9 hours, P<0.001). The percentage of diarrhea-free children was significantly larger in the LGG and BB-12 group at 72 hours compared to the control (60% vs. 33.8%, P<0.001). Mean length of hospital stay was similar for both groups (5.03 ± 2.3 days vs. 5.25 ± 1.3 days, P>0.05).

Conclusion This is the first clinical trial to test the combination of LGG and BB-12, and show its effects on diarrhea duration in children with acute infectious diarrhea. The duration of diarrhea was reduced by approximately 24 hours in the hospitalized children. Further randomized controlled clinical trials including outpatient cases with acute infectious diarrhea in addition to hospitalized cases should be conducted to assess the potential effects of the combination in more detail.

Anahtar Kelimeler

• probiotics
• LGG
• BB-12
• diarrhea
• hospitalization
• gastroenteritis
• Lactobacillus rhamnosus
• Lacticaseibacillus rhamnosus

Kaynakça

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