Condition category
Digestive System
Date applied
09/08/2007
Date assigned
17/08/2007
Last edited
02/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Taciana Duque-Braga

ORCID ID

Contact details

IMIP - UTI Neonatal
Rua dos Coelhos
300
Recife
50070-550
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Necrotising enterocolitis is an inflammatory bowel disease. It is the most common gastrointestinal emergency in neonates mainly associated with prematurity and inappropriate gastrointestinal colonisation by bacteria.

The study hypothesis is that the use of probiotics - Lactobacillus casei and Bifidobacterium breve - will have a positive impact on very low birth weight infants related to:
1. The reduction of the risk of necrotising enterocolitis
2. The reduction of the time span to reach the full enteral intake
3. The reduction of pathogenic bacteria in the faeces culture

Ethics approval

Ethical Committee in Research of the Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]) (Brazil) (c/o Prof Fernando Figueira) approved in August 2006.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Necrotising enterocolitis in very low birth weight infants.

Intervention

The participants will be randomised into two groups of 315 infants:

Control group: 3 ml of pasteurised human milk once a day on the second to the 30th day of life, or at the discharge if it happens before the 30th day.

Intervention group: Lactobacillus casei and Bifidobacterium breve (Yakult - LB) diluted with 3 ml of pasteurised human milk once a day on the second to the 30th day of life, or at the discharge if it happens before the 30th day.

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotics (Lactobacillus casei and Bifidobacterium breve)

Primary outcome measures

To compare the frequency of the necrotising enterocolitis classified as higher or equal to 2 according to Bell’s criteria modified by Walsh and Kleigman during the first 30 days of life.

Secondary outcome measures

1. To compare the frequency of pathogenic bacteria in the faeces tested weekly during the first month of life, in neonates treated with or without antibiotics; collecting stool samples (rectal swab) on 1, 7, 14 and 30 days of life, under sterile conditions and immediately transported to the bacteriology laboratory situated in the same building for processing
2. To compare the duration of birth weight recovery; assessment of the weight of the infants daily during the hospital stay
3. To compare the time taken to reach full enteral feeds - defined as a daily intake of 120 ml/Kg; across the diary registration of the enteral feeds volumes during the hospital stay
4. To compare the duration of hospital stay; the time between the admission and the discharge

Overall trial start date

01/09/2007

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Infants with birth weight from 750 g to 1500 g admitted in the Neonatal intensive Care Unit of the Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]).

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

630

Participant exclusion criteria

1. Newborns with severe congenital malformations
2. Newborns with severe chromosomal abnormalities

Recruitment start date

01/09/2007

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

IMIP - UTI Neonatal
Recife
50070-550
Brazil

Sponsor information

Organisation

Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]) (Brazil)

Sponsor details

Rua dos Coelhos
300 - Boa Vista
Recife
50070-550
Brazil

Sponsor type

Hospital/treatment centre

Website

http://www.imip.org.br/

Funders

Funder type

Government

Funder name

Laboratorio Yakult (www.yakultfarma.com.br) (Brazil) - providing the probiotics treatments

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute for Maternal/Infant Health (Instituto Materno Infantil [IMIP]) (Brazil) - c/o Prof Fernando Figueira, where study and assessments will be carried out

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The National Council of Scientific and Technologic Development (CNPq) (Brazil) - granted financial support to the research project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20980486

Publication citations

  1. Results

    Braga TD, da Silva GA, de Lira PI, de Carvalho Lima M, Efficacy of Bifidobacterium breve and Lactobacillus casei oral supplementation on necrotizing enterocolitis in very-low-birth-weight preterm infants: a double-blind, randomized, controlled trial., Am. J. Clin. Nutr., 2011, 93, 1, 81-86, doi: 10.3945/ajcn.2010.29799.

Additional files

Editorial Notes