ISRCTN ISRCTN78225533
DOI https://doi.org/10.1186/ISRCTN78225533
Secondary identifying numbers NTR313
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

St. Antonius Hospital
Department of Pediatrics
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands

Study information

Study designRandomised double-blind placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleTolerance for probiotics and its effect on growth and faeces of neonates
Study acronymPINGO (Probiotica in Neonatale Groei en Ontlasting)
Study objectivesProbiotics 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) studiedGut flora and growth parameters
InterventionAll infants receive formula feeding for the first three months, 75 with probiotics (L. casei and B. animalis) and 75 without.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Probiotics
Primary outcome measureGrowth parameters (weight, length and head circumference)
Secondary outcome measures1. Gut flora (tested with quantitative polymerase chain reaction [PCR])
2. Hours of crying, sleeping, etc
3. Defaecation patterns
Overall study start date01/11/2004
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants150
Key inclusion criteria1. Healthy, term neonate
2. Aged less than 7 days
3. Informed consent
4. Parents are fluent in Dutch
Key exclusion criteria1. Antibiotics postpartum
2. Congenital malformations, etc
Date of first enrolment01/11/2004
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

St. Antonius Hospital
Nieuwegein
3430 EM
Netherlands

Sponsor information

Friesland Foods (Netherlands)
Industry

Blankenstein 142
Meppel
7943 PE
Netherlands

Website http://www.nl.frieslandcampina.com/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan