A Phase 2 interventional study of Heat Inactivated probiotics and Placebo in Necrotizing Enterocolitis and Enterocolitis, Necrotizing, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 6 Hours to 7 Days. Per ClinicalTrials.gov, last updated 2016-06-16.
Sponsored by Shaare Zedek Medical Center · Phase 2, Interventional, and Prevention
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.
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:
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:
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's planned enrollment of 450 is above the median of 100 across 123 interventional studies indexed under Enterocolitis.
Browse Enterocolitis studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula.
Dietary Supplement: Placebo
Dietary Supplement: Heat Inactivated Probiotics 1 tsp heat inactivated Biotikid powder will be diluted in 2 cc of mother's milk (when available) or premature formula.
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
2 cc of milk will be given to control group
Necrotizing Enterocolitis, Bell Stage 2 or above, or Death
Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria
Time frame: Birth until 40 weeks post-conceptional age
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
Plan to share: No
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Shaare Zedek Medical Center