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
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