Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR313
Study information
Scientific title
Tolerance for probiotics and its effect on growth and faeces of neonates
Acronym
PINGO (Probiotica in Neonatale Groei en Ontlasting)
Study hypothesis
Probiotics are tolerated well by infants (age 0 - 3 months) and results in a microbial flora resembling that of breastfed infants.
Ethics approval
Received from 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
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Probiotics
Primary outcome measures
Growth parameters (weight, length and head circumference)
Secondary outcome measures
1. Gut flora (tested with quantitative polymerase chain reaction [PCR])
2. Hours of crying, sleeping, etc
3. Defaecation patterns
Overall trial start date
01/11/2004
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy, term neonate
2. Aged less than 7 days
3. Informed consent
4. Parents are fluent in Dutch
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Antibiotics postpartum
2. Congenital malformations, etc
Recruitment start date
01/11/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
St. Antonius Hospital
Nieuwegein
3430 EM
Netherlands
Sponsor information
Organisation
Friesland Foods (Netherlands)
Sponsor details
Blankenstein 142
Meppel
7943 PE
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