Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively 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

Mrs E. Smit

ORCID ID

Contact details

Medical Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR315

Study information

Scientific title

Acronym

POEMA trial

Study hypothesis

Prebiotics are present in breastfeeding and thus far not in premature formula, we presume that adding prebiotics to premature formula will be well tolerated, result in more loose stools compared to regular premature formula and will be responsible for gut flora which is present in breastfed infants.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Very low birth weight

Intervention

Adding prebiotics (galacto-oligosaccharides) to premature formula.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Prebiotic (galacto-oligosaccharides) supplementation

Primary outcome measures

1. Number of stools /day
2. Gut flora
3. Safety

Secondary outcome measures

Growth (increase in weight per kg per day)

Overall trial start date

01/05/2002

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Gestational age less then 34 weeks
2. Birth weight less then 1700 grams

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Congenital defects
2. Motility disorders of the gut
3. Necrotising enterocolitis
4. Medication with effects on gastric motility or intestinal flora (i.e., antibiotics)

Recruitment start date

01/05/2002

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medical Spectrum Twente,
Enschede
7500 KA
Netherlands

Sponsor information

Organisation

Friesland Coberco Dairy Foods Holding NV (Netherlands)

Sponsor details

Friesland Nutrition Research
P.O. Box 226
Leeuwarden
8901 MA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Friesland Coberco Dairy Foods Holding NV (Netherlands) - Friesland Nutrition Research

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

Publication citations

Additional files

Editorial Notes