Primary prevention of atopic disease by perinatal administration of probiotics
| ISRCTN | ISRCTN52995544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52995544 |
| Secondary identifying numbers | NTR323 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Dr M O Hoekstra
Scientific
Scientific
University Medical Centre Utrecht
Wilhelmina Children's Hospital
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 250 4001 |
|---|---|
| m.o.hoekstra@umcutrecht.nl |
Study information
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotics (Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium infantum) |
| Primary outcome measure | 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 study start date | 01/01/2004 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Hospital/treatment centre
Wilhelmina Children's Hospital (WKZ) (The Netherlands) - research fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
