Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea.
OBJECTIVE
To evaluate the efficacy and safety of Bifilac on reducing the episodes (frequency) and duration of diarrhea induced by rotaviral infection and to evaluate the efficacy of Bifilac 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).


CONCLUSIONS
The synbiotic, bifilac, appears to be a safe and very effective adjuvant in the management of acute rotaviral diarrhea.
Narayanappa
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Departments of Pediatrics, J.S.S. Medical College Hospital, Ramanuja Road, Mysore, India. sinchabhi@yahoo.com
D000208:Acute Disease; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D003681:Dehydration / Q000188:drug therapy; D003967:Diarrhea / Q000188:drug therapy* / Q000821:virology*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005440:Fluid Therapy; D006801:Humans; D007223:Infant; D008297:Male; D009113:Muramidase / Q000627:therapeutic use*; D019936:Probiotics / Q000627:therapeutic use; D015532:Rehydration Solutions / Q000627:therapeutic use; D012401:Rotavirus / Q000302:isolation & purification / Q000502:physiology; D012400:Rotavirus Infections / Q000188:drug therapy* / Q000821:virology*; D016896:Treatment Outcome; D017201:Virus Shedding
D000890:Anti-Infective Agents; D004338:Drug Combinations; D015532:Rehydration Solutions; D009113:Muramidase