Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr M O Hoekstra
ORCID ID
Contact details
University Medical Centre Utrecht
Wilhelmina Children's Hospital
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4001
m.o.hoekstra@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR323
Study information
Scientific title
Acronym
PANDA
Study hypothesis
Administration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence of or in a decrease of the severity of atopic disease during infancy.
Ethics approval
Received from the 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
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Allergy, atopic disease, pregnancy
Intervention
A combination of probiotics (Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium infantum), each 1000 million daily, added to the formula used.
Intervention type
Drug
Phase
Not Specified
Drug names
Probiotics (Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium infantum)
Primary outcome measures
Incidence and severity of atopic disease at the age of 2 years.
Secondary outcome measures
1. SCORAD
2. Lung function
3. Serum IgE (total and specific)
4. Cytokines produced by peripheral blood derived mononuclear cells
5. Bacterial content of stools during the first weeks of life
Overall trial start date
01/01/2004
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant mothers were included if either they themselves or their husband plus a sibling suffered from present or past atopic disease.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Maternal use of immunomodulatory drugs during pregnancy
2. The use of probiotics
Recruitment start date
01/01/2004
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Wilhelmina Children's Hospital (WKZ) (The Netherlands) - research fund
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