Primary prevention of atopic disease by perinatal administration of probiotics

ISRCTN	ISRCTN52995544
DOI	https://doi.org/10.1186/ISRCTN52995544
Protocol serial number	NTR323
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funder	Wilhelmina Children's Hospital (WKZ) (The Netherlands) - research fund

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

Dr M O Hoekstra
Scientific

University Medical Centre Utrecht
Wilhelmina Children's Hospital
P.O. Box 85090
Utrecht
3508 AB
Netherlands

Phone	+31 (0)30 250 4001
Email	m.o.hoekstra@umcutrecht.nl

Primary study design	Interventional
Study design	Randomised, double-blind, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PANDA
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Probiotics (Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium infantum)
Primary outcome measure(s)	Incidence and severity of atopic disease at the age of 2 years.
Key secondary outcome measure(s)	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
Completion date	01/01/2009

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	120
Key inclusion criteria	Pregnant mothers were included if either they themselves or their husband plus a sibling suffered from present or past atopic disease.
Key exclusion criteria	1. Maternal use of immunomodulatory drugs during pregnancy 2. The use of probiotics
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2009

University Medical Centre Utrecht

Utrecht
3508 AB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes