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Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies

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ClinicalTrials.gov Identifier: NCT00977912
Recruitment Status : Terminated
First Posted : September 16, 2009
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Necrotizing Enterocolitis Dietary Supplement: Probiotic supplementation Dietary Supplement: Milk containing placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of NEC in Preterm Infants With B. Lactis
Study Start Date : November 2009
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: "Milk" containing B. Lactis
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Dietary Supplement: Probiotic supplementation
one capsule containing probiotics per day added to milk
Placebo Comparator: "Milk" containing placebo
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Dietary Supplement: Milk containing placebo
one capsule containing placebo per day added to milk


Outcome Measures

Primary Outcome Measures :
  1. NEC onset [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Antibiotic administration and stool microbiology [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

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): NCT00977912


Locations
South Africa
University of Witwatersrand & Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Johannesburg, South Africa, 2000
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Johannesburg, South Africa, 2112
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Peter A. Cooper, MD University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00977912     History of Changes
Other Study ID Numbers: 08.09.INF
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
B. lactis
Preterm
Necrotizing Enterocolitis (NEC)

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases