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
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 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(s) | Received from the local medical ethics committee |
| 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 |
| 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 |
| Overall study end date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 120 |
| 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 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
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 |
