Clinical Trial: Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary:

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

Sponsor: Shaare Zedek Medical Center

Current Primary Outcome: Necrotizing Enterocolitis, Bell Stage 2 or above, or Death [ Time Frame: Birth until 40 weeks post-conceptional age ]

Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Increased Urine IFABP Levels [ Time Frame: Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age ]
  • Increased Fecal Calprotectin Levels [ Time Frame: Weekly, from date of randomization until full enteral feeds (100 cc/kg/day) achieved or until death or necrotizing enterocolitis is diagnosed, whichever comes first until 37 weeks postconceptional age ]


Original Secondary Outcome: Same as current

Information By: Shaare Zedek Medical Center

Dates:
Date Received: May 22, 2016
Date Started: June 2016
Date Completion: September 2020
Last Updated: June 15, 2016
Last Verified: June 2016