NCT02796703

Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis (NEC) in Premature Neonates

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 6 Hours – 7 Days
• Healthy volunteers: Not accepted

Summary

Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.

Detailed description

Preterm neonates, \<1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. The infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in Similac Special Care formula 24 cal when mother's milk is not available; and 2. Control group - to receive 2 cc/day of placebo similarly diluted. Supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes LAST). Biotikid, a probiotic mixture, will be heated to 100 degrees C for 10 minutes. Babies will be followed clinically for signs of NEC, and with urine intestinal fatty acid binding protein (IFABP) and fecal calprotectin levels. The investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo. The investigators secondary objectives are to demonstrate the following: * That the decrease in NEC will coincide with improved intestinal barrier integrity, as reflected by levels of: * I-FABP in urine * Fecal Calprotectin

Conditions

• Necrotizing Enterocolitis
• Enterocolitis, Necrotizing

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Heat Inactivated probiotics	Biotikid, a probiotic mixture, will be heated to 100 degrees Centigrade for 10 minutes to inactivate and then 1 tsp will be diluted in milk and give with feeds to treatment group
DIETARY_SUPPLEMENT	Placebo	2 cc of milk will be given to control group

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-07-01
• Completion: 2020-09-01
• First posted: 2016-06-13
• Last updated: 2016-06-16

Locations

1 site across 1 country: Israel