NCT02796703

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

4.1 years

First QC Date

May 22, 2016

Last Update Submit

June 15, 2016

Conditions

Necrotizing EnterocolitisEnterocolitis, Necrotizing

Outcome Measures

Primary Outcomes (1)

  • Necrotizing Enterocolitis, Bell Stage 2 or above, or Death

    Necrotizing Enterocolitis diagnosis will be based on clinical and radiographic criteria

    Birth until 40 weeks post-conceptional age

Secondary Outcomes (2)

  • Increased Urine IFABP Levels

    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

    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

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Treatment Group

ACTIVE COMPARATOR

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

Interventions

Heat Inactivated probioticsDIETARY_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

Treatment Group
PlaceboDIETARY_SUPPLEMENT

2 cc of milk will be given to control group

Control Group

Eligibility Criteria

Age6 Hours - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonates
  • ≤1500 gm birth weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20506712BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Cathy Hammerman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Hammerman, MD

CONTACT

0508685238cathyh@ekmd.huji.ac.il

Alona Bin-Nun, MD

CONTACT

0508685757alona.binnun@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Division Newborn Nurseries

Study Record Dates

First Submitted

May 22, 2016

First Posted

June 13, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

June 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)