Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arine M Vlieger

ORCID ID

Contact details

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

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

http://www.nl.frieslandcampina.com/

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

Publication citations

Additional files

Editorial Notes