Abstract

A Randomized Open Label Comparative Clinical Study of a Probiotic against a Symbiotic in the Treatment of Acute Diarrhoea in Children

Author(s):Ramchandra Bastola, Bhawana Sigdel Bastola, Rupa Gurung, Jagat Jeevan Ghimire and Shree Krishna Shrestha

Objective: To evaluate the safety, efficacy and tolerability of a probiotic against a symbiotic in reducing the frequency and the duration of acute diarrhoea. Methods: One hundred children aged 6 months to 6 years, with acute diarrhoea, admitted in the paediatric ward of Pokhara Academy of Health Sciences (PAHS) were recruited in the study. Group A (n=50) received standard therapy plus probiotic 5 mL (Enterogermina®) twice-daily for 7 days. Group B (n=50) received standard treatment plus symbiotic 5 mL (Bifilac® dry syrup) twice-daily for 7 days. Patients were assessed for diarrhoea and dehydration. Results: The frequency of diarrhoea was reduced from 9.03 on Day 1 to 0.81 on Day 3 in Group B, compared with 10.1 on Day 1 to 6.24 on Day 3 in Group A. On comparing the two groups on Day 3, Group A produced a statistically significant reduction in the frequency of diarrhoea. Similarly, there was a statistically significant reduction in the duration of diarrhoea on comparing Group A with Group B. The mean duration of diarrhoea was 36.2 hours in Group B, compared with 72.6 hours in Group A. The adverse events were mild and no serious adverse effects were reported. Conclusion: From our study, it can be concluded that the symbiotic is more effective in reducing the frequency and duration of diarrhoea then the probiotic and is well-tolerated.

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