Randomized trial investigating Lactobacillus acidophilus LA-5 and Bifidobacterium BB -12 (Providac) capsules for prevention of antibiotic-associated diarrhea in Indian patients
International Conference and Exhibition on Food Processing & Technology
November 22-24, 2012 Hyderabad International Convention Centre, India

Amit Bhalla

Accepted Abstracts: J Food Process Techno

Abstract:

The role of probiotics in antibiotic-associated diarrhoea [AAD] has not been well studied. This trial evaluated the efficacy and safety of Providac capsules in the prevention of AAD in Indian patients. Patients of either gender who required a systemic oral antibiotic therapy for 7 days were randomized into Providac capsules (Lactobacillus acidophilus LA-5, 500 million colony forming units and Bifidobacterium BB -12, 500 million colony forming units) or placebo treatment, 2 capsules administered twice daily after food for 14 days, in a double blind placebo controlled multicentric trial design, and followed up. The primary outcome was incidence of AAD while secondary outcomes of duration and severity of diarrhea were evaluated. Evaluable subjects, 176 in the Providac group while 167 in the placebo group, had comparable baseline profiles. After 14 days therapy, incidence of AAD in the Providac group was 10.8% compared to 15.56% in the placebo group (p=0.19). The duration of diarrhea was significantly less (p=0.010) in the Providac group (2.32 ?2.31 days) compared to the placebo (4.58 ?3.08 days) group. Severe diarrhoea ? (manifested as watery stool) was more in the Placebo group (96%) than the Providac group (31.6%) and this difference was highly significant statistically (p<0.0001). There were mild and self limiting adverse drug effects observed in both groups. Thus we conclude that in Indian adult patients with AAD, Providac can effectively reduce the duration of diarrhea as well as its severity.

Biography :

Amit Bhalla has Medical degree (from University of Calicut 1998), and postgraduate degree in Pharmacology (from Baba Farid university of Health Sciences, 2006), currently holding the position of Medical Adviser to a leading pharmaceutical company, Zydus Cadila, Ahmedabad. He is involved in conducting CME programmes all across India and try to develop and train local speakers. He has taught undergraduate medical students at tertiary care institution from 2003 to 2006. Activities involve new product tracking, identification of prospective lead molecules.