Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
06/05/2014
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

Dr Ruurd M van Elburg

ORCID ID

Contact details

VU University Medical Centre
Department of Pediatrics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2413
rm.vanelburg@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR884

Study information

Scientific title

Acronym

CARROT study

Study hypothesis

Acidic and neutral oligosaccharides supplemented enteral nutrition has a positive effect on infectious morbidity, modulation of the immune response, postnatal adaptation of the gut, feeding tolerance and short-term outcome in Very Low Birth Weight (VLBW) infants.
2006 literature review on http://www.ncbi.nlm.nih.gov/pubmed/16677741.

Ethics approval

Medical Ethics Committee VU Medical Centre, 15/02/2007

Study design

Randomised placebo-controlled factorial double-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Prebiotics, gastrointestinal tract, preterm infants, immune effects

Intervention

Enteral supplementation of acidic and neutral oligosaccharides (20%/80% mixture) in a maximum dose of 1.5 g/kg/day during the first month of life.

Intervention type

Supplement

Phase

Not Specified

Drug names

Enteral supplementation of acidic and neutral oligosaccharides

Primary outcome measures

1. The effect of acidic and neutral oligosaccharides supplemented enteral feeding on infectious morbidity
2. The incidence of serious infections, using the previously described criteria for serious infections in preterm infants at high risk for serious infections, are prospectively documented from birth until discharge home

Secondary outcome measures

The effect of acidic and neutral oligosaccharides supplemented enteral nutrition on feeding tolerance, short-term outcome, postnatal adaptation of the gut and modulation of the immune response

Overall trial start date

01/04/2007

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500g

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

108

Participant exclusion criteria

1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders
2. Congenital disorders of the gastrointestinal tract

Recruitment start date

01/04/2007

Recruitment end date

01/04/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Paediatrics and Neonatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 4444
w.fetter@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/#http://www.vumc.nl/english/

Funders

Funder type

Industry

Funder name

Numico Research B.V. (Netherlands)

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. 2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18947426
2. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/20032496
3. 2011 external supplementation results in: http://www.ncbi.nlm.nih.gov/pubmed/20863418
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23951035

Publication citations

  1. Protocol

    Westerbeek EA, van Elburg RM, van den Berg A, van den Berg J, Twisk JW, Fetter WP, Lafeber HN, Design of a randomised controlled trial on immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: carrot study., BMC Pediatr, 2008, 8, 46, doi: 10.1186/1471-2431-8-46.

  2. Results

    Westerbeek EA, van den Berg JP, Lafeber HN, Fetter WP, Boehm G, Twisk JW, van Elburg RM, Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial., Am. J. Clin. Nutr., 2010, 91, 3, 679-686, doi: 10.3945/ajcn.2009.28625.

  3. External supplementation results

    Westerbeek EA, van den Berg A, Lafeber HN, Fetter WP, van Elburg RM, The effect of enteral supplementation of a prebiotic mixture of non-human milk galacto-, fructo- and acidic oligosaccharides on intestinal permeability in preterm infants., Br. J. Nutr., 2011, 105, 2, 268-274, doi: 10.1017/S0007114510003405.

  4. Results

    van den Berg JP, Westerbeek EA, van der Klis FR, Berbers GA, Lafeber HN, van Elburg RM, Neutral and acidic oligosaccharides supplementation does not increase the vaccine antibody response in preterm infants in a randomized clinical trial., PLoS ONE, 2013, 8, 8, e70904, doi: 10.1371/journal.pone.0070904.

Additional files

Editorial Notes