Study name	Phase III, multicentre, randomized, double‐blind, placebo‐controlled study to evaluate efficacy of probiotic supplementation for prevention of neonatal sepsis in 0–2 months old low birth weight infants in India
Methods	Randomized, parallel group, placebo controlled trial
Participants	Inclusion criteria:
	1.Birth weight: 1500 g to 500 g 2.Age of the new‐born Day 3‐7 on recruitment, that is, not later than 7th day 3.Stable clinical condition as assessed by physician and accepting feeds orally (where stable is defined as, does not require intravenous fluids and vasopressor medication to maintain circulation and accepts oral feeding or breastfeeding). 4.The mother (with the new‐born) is planning to stay in study area for a period of at least 2 months
	Exclusion criteria:
	1.New born with extreme prematurity, that is, <34 weeks 2.New born with illness requiring prolonged hospitalisation and interference with oral feeding 3.Presence of a gross congenital malformation incompatible with life 4.Parent or Legally authorized representative (LAR) not providing written consent
Interventions	Intervention 1: Vivomixx Drops, that is, Lactic acid bacteria and Bifidobacteria drop with medium chain triglyderide oil.
	1.Each bottle cap contains at least 50 Billion Lactic acid bacteria and Bifidobacteria a. Streptococcus thermophilus DSM 24731 b. Bifidobacterium longum DSM 24736, B. breve DSM 24732 and B. infantis DSM 24737) c. Lactobacillus acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, and L. delbrueckii subs. bulgaricus DSM 24734 2.Each bottle contains MCT, that is, Medium chain triglyceride oil 5 ml.
	The contents of the cap should be mixed with MCT oil and shaken well prior to administration. Store in refrigerator at 2–8°C: 1 ml per day for 30 days (corresponding to NLT 10 billion CFU per day)
	Control Intervention 1: Placebo Drops
	1.Each Bottle cap contains Maltodextrin 2.Each bottle contains MCT, that is, Medium chain triglyceride oil 5 ml
	The contents of the cap should be mixed with MCT oil and shaken well prior to administration. Store in refrigerator at 2‐ 8 degrees centigrade.: 1 ml per day for 30 days
Outcomes	1.Sepsis 2.Possible serious bacterial infections (PSBIs). Timepoint: 60 days
Starting date	Date of first enrolment: 01‐12‐2019
Contact information	Division of Reproductive, Maternal and Child Health
	Ansari Nagar, New Delhi
	South
	DELHI
	110029
	India
Notes	Study started in Jan 2019