The effects of a prebiotic supplement of faecal consistency, mineral absorption and gut flora in low birth weight infants
| ISRCTN | ISRCTN87058658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87058658 |
| Secondary identifying numbers | NTR315 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs E. Smit
Scientific
Scientific
Medical Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands
Study information
| Study design | Randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | POEMA trial |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Very low birth weight |
| Intervention | Adding prebiotics (galacto-oligosaccharides) to premature formula. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Number of stools /day 2. Gut flora 3. Safety |
| Secondary outcome measures | Growth (increase in weight per kg per day) |
| Overall study start date | 01/05/2002 |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 34 Weeks |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Gestational age less then 34 weeks 2. Birth weight less then 1700 grams |
| Key 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) |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medical Spectrum Twente,
Enschede
7500 KA
Netherlands
7500 KA
Netherlands
Sponsor information
Friesland Coberco Dairy Foods Holding NV (Netherlands)
Industry
Industry
Friesland Nutrition Research
P.O. Box 226
Leeuwarden
8901 MA
Netherlands
"ROR" |
https://ror.org/025mtxh67 |
|---|
Funders
Funder type
Industry
Friesland Coberco Dairy Foods Holding NV (Netherlands) - Friesland Nutrition Research
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
