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Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

NCT02796703 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-06-16

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis
  • Enterocolitis, Necrotizing

Interventions

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

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Cathy Hammerman, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Hours
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-07-31
Completion
2020-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796703 on ClinicalTrials.gov