Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy of Probiotic Supplementation for Prevention of Neona

Summary (layman): Neonatal infections are a major cause of sickness and death in infancy in the developing countries. Treatment with antibiotics has limitation as the bacteria have become resistant and there is dearth of new antibiotics. At present there is lack of knowledge about how to prevent the disease. Current trial aims to find out if feeding probiotics daily for 30 days during the first month of life would prevent these infections. Remaining healthy in the first month is important as it allows the newborns to grow to become healthy adults. The study would be coordinated by three research organizations and implemented at six sites in India. 6500 Newborn infants weighing less than 2500gms would be allocated to either the probiotics or a placebo group without the study participants' or researchers' knowledge of the group assignment. They would be fed the assigned drug and followed up in their homes regularly upto 60 days by trained field workers (daily in the first week, biweekly during 2-4 weeks of life, and weekly during the second month) to find out if they fell sick. Sick infants would be referred/taken to study physician for examination, testing and treatment. All study related information would be captured on Tablets/hand held devices and sent to a central location for analysis. After completion of the study the data would be analysed to see whether there were less infections/sepsis cases in the group where infants were fed with probiotics as compared to the other group. If the results favour the probiotics it could be used as a new method of preventing neonatal infections in the developing countries. This would benefit millions of newborns who are currently dying due to infections.