NCT00977912

Brief Summary

The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

3.8 years

First QC Date

September 15, 2009

Last Update Submit

November 22, 2013

Conditions

Necrotizing Enterocolitis

Keywords

B. lactisPretermNecrotizing Enterocolitis (NEC)

Outcome Measures

Primary Outcomes (1)

  • NEC onset

    6 weeks

Secondary Outcomes (1)

  • Antibiotic administration and stool microbiology

    6 weeks

Study Arms (2)

"Milk" containing B. Lactis

EXPERIMENTAL

"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Dietary Supplement: Probiotic supplementation

"Milk" containing placebo

PLACEBO COMPARATOR

"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Dietary Supplement: Milk containing placebo

Interventions

Probiotic supplementationDIETARY_SUPPLEMENT

one capsule containing probiotics per day added to milk

"Milk" containing B. Lactis
Milk containing placeboDIETARY_SUPPLEMENT

one capsule containing placebo per day added to milk

"Milk" containing placebo

Eligibility Criteria

Age12 Hours - 48 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Weight between 800 - 1500g
  • Tolerating enteral feeding within 48 hours
  • Having obtained his/her parents or legal representative informed consent

You may not qualify if:

  • Chromosomal abnormality
  • Hydrops featalis
  • Congenital malformation of the gastrointestinal tract
  • Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
  • Currently participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Witwatersrand & Chris Hani Baragwanath Hospital

Bertsham, 2013, South Africa

Location

University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital

Johannesburg, 2000, South Africa

Location

University of Witwatersrand & Rahima Moosa Mother & Child Hospital

Johannesburg, 2112, South Africa

Location

Related Publications (2)

  • Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.

    PMID: 37493095DERIVED

  • Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.

    PMID: 33058137DERIVED

MeSH Terms

Conditions

Enterocolitis, NecrotizingPremature Birth

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Peter A. Cooper, MD

    University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

ZA(3)