Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

NCT ID: NCT02796703

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-09-30

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 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

Conditions

Necrotizing Enterocolitis; Enterocolitis, Necrotizing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group

Dietary Supplement: Placebo 2 cc/day of placebo diluted in mother's milk (when available) or premature formula.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2 cc of milk will be given to control group

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.

Group Type: ACTIVE_COMPARATOR

Heat Inactivated probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2 cc of milk will be given to control group

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 6 Hours
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cathy Hammerman

Director Division Newborn Nurseries

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Central Contacts

Cathy Hammerman, MD

Role: CONTACT

cathyh@ekmd.huji.ac.il

0508685238

Alona Bin-Nun, MD

Role: CONTACT

alona.binnun@gmail.com

0508685757

References

Awad H, Mokhtar H, Imam SS, Gad GI, Hafez H, Aboushady N. Comparison between killed and living probiotic usage versus placebo for the prevention of necrotizing enterocolitis and sepsis in neonates. Pak J Biol Sci. 2010 Mar 15;13(6):253-62. doi: 10.3923/pjbs.2010.253.262.

Reference Type: BACKGROUND

PMID: 20506712 (View on PubMed)

Other Identifiers

SZMC 0297-15

Identifier Type: -

Identifier Source: org_study_id