Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kinderallergologie.nl

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

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

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

Publication citations

Additional files

Editorial Notes