We conducted a double-blind randomized placebo-controlled study to evaluate efficacy and tolerability of VSL[sharp]3 (CD Pharma India) in the treatment of acute rotavirus diarrhea in children. The patients were randomly assigned to receive 4 days of oral treatment with VSL[sharp]3 probiotic mixture or placebo in addition to usual care for diarrhea.
Results: Out of 230 rotavirus-positive acute diarrhea children, 224 children completed the study, (113 in the drug group and 111 in the placebo group). At recruitment on Day 1, there were no significant differences between the 2 groups in terms of frequency of vomiting, mean loose stool frequency, stool consistency, and mean frequency of oral rehydration salts (ORS) and intravenous fluids administered. On Day 2, a lower mean stool frequency and improved stool consistency was noted in the drug group, which achieved statistical significance. This was also reflected in the lower volume of ORS administration in the drug group. Even on Day 3, mean loose stool frequency and frequency of ORS use and frequency of intravenous fluid use was significantly lower in the drug group. The differences in the frequency of loose stools persisted till 8 hours of Day 4. After this, as the placebo group also showed spontaneous improvement the difference between the 2 groups in terms of the overall stools frequency became comparable. However, the overall ORS requirement continued to be significantly lower in the drug group even on Day 4. The overall recovery rates were significantly better in the drug group compared with placebo. No side effects were noted with the use of the probiotic mixture. Use of probiotic mixture VSL[sharp]3 in acute rotavirus diarrhea resulted in earlier recovery and reduced frequency of ORS administration reflecting decreased stool volume losses during diarrhea.