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Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

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ClinicalTrials.gov Identifier: NCT02796703
Recruitment Status : Not yet recruiting
First Posted : June 13, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Enterocolitis, Necrotizing Dietary Supplement: Heat Inactivated probiotics Dietary Supplement: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis (NEC) in Premature Neonates
Study Start Date : June 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula.
Dietary Supplement: Placebo
2 cc of milk will be given to control group

Active Comparator: Treatment Group

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm neonates
  • ≤1500 gm birth weight

Exclusion Criteria:

  • Infants who are not deemed likely to survive more than one week;
  • Infants who are not started on enteral feeds by one week of age;
  • Infants who have significant congenital malformations or other gastrointestinal problem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796703


Contacts
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Contact: Cathy Hammerman, MD 0508685238 cathyh@ekmd.huji.ac.il
Contact: Alona Bin-Nun, MD 0508685757 alona.binnun@gmail.com

Locations
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Israel
Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

Publications:
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Responsible Party: Cathy Hammerman, Director Division Newborn Nurseries, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02796703     History of Changes
Other Study ID Numbers: SZMC 0297-15
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases