Tolerance of probiotics in the neonate
| ISRCTN | ISRCTN78225533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78225533 |
| Protocol serial number | NTR313 |
| Sponsor | Friesland Foods (Netherlands) |
| Funder | Friesland Coberco Dairy Foods Holding NV (Netherlands) - Friesland Nutrition Research |
- 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
Dr Arine M Vlieger
Scientific
Scientific
St. Antonius Hospital
Department of Pediatrics
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Tolerance for probiotics and its effect on growth and faeces of neonates |
| Study acronym | PINGO (Probiotica in Neonatale Groei en Ontlasting) |
| Study objectives | Probiotics are tolerated well by infants (age 0 - 3 months) and results in a microbial flora resembling that of breastfed infants. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Gut flora and growth parameters |
| Intervention | All infants receive formula feeding for the first three months, 75 with probiotics (L. casei and B. animalis) and 75 without. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Probiotics |
| Primary outcome measure(s) |
Growth parameters (weight, length and head circumference) |
| Key secondary outcome measure(s) |
1. Gut flora (tested with quantitative polymerase chain reaction [PCR]) |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Healthy, term neonate 2. Aged less than 7 days 3. Informed consent 4. Parents are fluent in Dutch |
| Key exclusion criteria | 1. Antibiotics postpartum 2. Congenital malformations, etc |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St. Antonius Hospital
Nieuwegein
3430 EM
Netherlands
3430 EM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
