Effect of Silica-Based Enterosorbent Use on Diarrhea Duration in Children with Rotavirus Gastroenteritis: A Multicenter, Two-Group Comparative Study

Abstract

Objective: This study aimed to evaluate the effect of adding Colloidal Silicon Dioxide to standard outpatient treatment on the clinical course of children aged 2–14 years with rotavirus antigen–positive acute gastroenteritis. Materials and Methods: A two-group comparative analysis was conducted in rotavirus-positive children managed on an outpatient basis. The treatment groups were standard therapy (oral rehydration + zinc + probiotic) and standard therapy plus Colloidal Silicon Dioxide. A total of 300 children with confirmed rotavirus infection were included across five different hospitals: 150 received standard therapy alone and 150 received additional Colloidal Silicon Dioxide. The study was designed as a multicenter, multisite, two-group comparative study. The follow-up window was Day 0–7. The primary endpoint was time to diarrhea resolution, defined as the first day with stool frequency ≤3/day and a Bristol Stool Scale score ≤5. Secondary endpoints included total stool count, stool type and consistency, fever course, hospital revisits, school and work absenteeism, and product safety. Appropriate parametric or nonparametric tests were used for continuous variables; Fisher’s exact test for categorical variables; and Kaplan–Meier analysis with log-rank testing for diarrhea resolution (p < 0.05). Results: A total of 300 children (standard therapy n = 150; standard therapy plus Colloidal Silicon Dioxide n = 150) were analyzed. The mean age was 6.6 years in both groups. Median time to diarrhea resolution was 7.0 (6.0–8.0) days in the standard therapy group versus 2.0 (1.0–2.0) days in the Colloidal Silicon Dioxide group (log-rank p < 0.001). By Day 7, diarrhea resolution rates were 60.0% (90/150) in the standard group and 100.0% (150/150) in the Colloidal Silicon Dioxide group. The cumulative stool burden during Days 0–7 was significantly lower in the Colloidal Silicon Dioxide group (p < 0.001). The number of febrile days and the time to the last loose/watery stool were also significantly shorter in the Colloidal Silicon Dioxide group (p < 0.001). Intravenous fluid requirement and revisit rates were lower in the Colloidal Silicon Dioxide group. Conclusion: In rotavirus-positive children managed on an outpatient basis, the addition of Colloidal Silicon Dioxide to standard therapy reduced symptom burden and healthcare utilization and significantly accelerated clinical recovery.

Keywords

• rotavirus
• acute gastroenteritis
• child
• enterosorbent
• colloidal silicon dioxide

Çocuklarda Rotavirüs Gastroenteritinde Silika Bazlı Enterosorbent Kullanımının Diyare Süresine Etkisi: Çok Merkezli, Multisentrik, İki Grup Karşılaştırmalı Çalışma

Abstract

Amaç: Bu çalışmada, rotavirüs antijen testi pozitif akut gastroenteritli 2–14 yaş çocuklarda ayaktan standart tedaviye Kolloidal Silisyum Dioksit eklenmesinin klinik seyir üzerine etkisini değerlendirmek amaçlandı. Kolloidal Silisyum Dioksit Gereç ve Yöntem: Rotavirüs pozitif ayaktan izlenen çocuklarda iki gruplu karşılaştırmalı analiz yapıldı (Standart tedavi: sıvı + çinko + probiyotik; Standart+ Kolloidal Silisyum Dioksit. Çalışma toplam 5 ayrı hastanede standart tedavi verilen 150 ve standart tedaviye ek olarak Kolloidal Silisyum Dioksit kullanan 150 Rotavirüs tanılı çocuk dahil edilidi. Çalışmamız çok merkezli, multisentrik ve iki grup karşılaştırmalı olarak planlandı. Çalışma Takip penceresi Gün 0–7 idi. Primer sonlanım ishalin düzelmesine kadar geçen süre olarak tanımlandı (ilk kez dışkı sayısı ≤3/gün ve Bristol ≤5 sağlanması). İkincil sonlanımlar toplam dışkı sayısı, dışkı tipi, dışkı kıvamı, ateş seyri, hastaneye başvuru, okul ve işgücü kaybı ve ürün güvenliği idi. Sürekli değişkenlerde uygun parametrik/parametrik olmayan testler; ikili değişkenlerde Fisher kesin testi; ishal düzelme için Kaplan-Meier ve log-rank testi kullanıldı (p<0,05). Bulgular: Toplam 300 çocuk (Standart n=150; Standart+ Kolloidal Silisyum Dioksit n=150) analiz edildi. Yaş ortalaması her iki grupta 6,6 yıl idi. İshal düzelme süresi Standart grupta 7,0 (6,0–8,0) gün iken Kolloidal Silisyum Dioksit grubunda 2,0 (1,0–2,0) gün bulundu (log-rank p=<0,001); 7. gün sonunda düzelme oranı sırasıyla %60,0 (90/150) ve %100,0 (150/150) idi. 0–7 gün dışkı yükü Kolloidal Silisyum Dioksit grubunda daha düşüktü (p<0,001). Ateşli gün sayısı ve son lapa/sulu dışkı günü Kolloidal Silisyum Dioksit grubunda anlamlı olarak daha kısa bulundu (p<0,001). İV sıvı ihtiyacı ve tekrar başvuru oranları Kolloidal Silisyum Dioksit grubunda daha düşüktü. Sonuç: Rotavirüs pozitif ayaktan çocuklarda standart tedaviye Kolloidal Silisyum Dioksit eklenmesi semptom yükünü ve sağlık hizmeti kullanımını azaltmış, klinik iyileşmeyi hızlandırmıştır.

Keywords

• rotavirüs
• akut gastroenterit
• çocuk
• enterosorbent
• koloidal silisyum dioksit

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