No registrations found.
ID
Source
Brief title
Health condition
A randomised double-blind intervention study in pregnant mothers from atopic families and in their newborns.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence and severity of atopic disease at the age of 2 years.
Secondary outcome
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.
Background summary
Inclusion of pregnant mothers from atopic families has ended. Around January first 2006 all children are born. Results on cord blood analysis are expected in spring of 2006. Clinicial data at the age of 3 months are expected just before the summer of 2006.
Study objective
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.
Intervention
A combination of probiotics (Lact.Lactis, B.Bifidum, B.Infantum), each 1000 milion daily, added to the the formula used.
Wilhelmina Children's Hospital,
P.O. Box 85090
M.O. Hoekstra
Lundlaan 6
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
m.o.hoekstra@umcutrecht.nl
Wilhelmina Children's Hospital,
P.O. Box 85090
M.O. Hoekstra
Lundlaan 6
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
m.o.hoekstra@umcutrecht.nl
Inclusion criteria
Pregnant mothers were included if either they themselves or their husband plus a sibling suffered from present or past atopic disease.
Exclusion criteria
1. Maternal use of immunomodulatory drugs during pregnancy;
2. The use of probiotics.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL285 |
| NTR-old | NTR323 |
| Other | : N/A |
| ISRCTN | ISRCTN52995544 |