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Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea

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Abstract

Objective

To evaluate the efficacy and safety of Bifilacℳ on reducing the episodes (frequency) and duration of diarrhea induced by rotaviral infection and to evaluate the efficacy of Bifilacℳ to ameliorate the associated symptoms like dehydration and duration of rotaviral shedding in faeces.

Methods

80 children aged between 3 months and 3 years were enrolled and divided into 2 groups, one group received standard therapy + placebo, the other group received standard therapy + probiotic (Bifilac) randomly. Children assessed for frequency and duration of diarrhea. Degree of dehydration, duration and volume of oral rehydration salt [ORS] therapy, duration and volume of Intra venous fluids and duration of rotaviral shedding.

Results

When compared to the placebo, Bifilac showed clinical as well as statistically significant reduction in Number of episodes (frequency) of diarrhea in a day, mean duration of diarrhea (in days) degree of dehydration, duration and volume of oral rehydration salt [ORS] therapy, duration and volume of intravenous fluid [IVF] therapy, duration of rotaviral shedding (P<0.01).

Conclusion

The synbiotic, bifilac, appears to be a safe and very effective adjuvant in the management of acute rotaviral diarrhea.

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Authors and Affiliations

  1. Departments of Pediatrics, J.S.S. Medical College Hospital, Ramanuja Road, Mysore, India

    D. Narayanappa

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  1. D. Narayanappa
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Correspondence to D. Narayanappa.

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Narayanappa, D. Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea. Indian J Pediatr 75, 709–713 (2008). https://doi.org/10.1007/s12098-008-0134-2

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  • DOI: https://doi.org/10.1007/s12098-008-0134-2

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