Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02796703
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact	Cathy Hammerman, MD
Phone	0508685238
Email	cathyh@ekmd.huji.ac.il
Status	Not yet recruiting
Phase	Phase 2
Start date	June 2016
Completion date	September 2020

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT03210831` - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Recruiting	`NCT02552706` - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis	N/A
Completed	`NCT02400697` - Placental Transfusion Project for Preterm Infants	N/A
Completed	`NCT01751477` - Infloran® for Prevention of Necrotizing Enterocolitis	N/A
Terminated	`NCT01156480` - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
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Recruiting	`NCT01441739` - Intestinal Failure in Necrotising Enterocolitis	N/A
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Recruiting	`NCT04074824` - A Genome-Wide Association Study for Neonatal Diseases
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Active, not recruiting	`NCT03554278` - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting	`NCT04541771` - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants	Phase 2
Not yet recruiting	`NCT03700957` - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed	`NCT01735578` - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis	N/A
Completed	`NCT01745510` - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates	Phase 1/Phase 2
Unknown status	`NCT01807858` - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.