Probiotics in Atopic Dermatitis in Infancy
| ISRCTN | ISRCTN41490500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41490500 |
| Secondary identifying numbers | 01.19.NRC |
- Submission date
- 27/10/2005
- Registration date
- 28/11/2005
- Last edited
- 01/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Clare Murray
Scientific
Scientific
NWLRC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 4199 |
|---|
Study information
| Study design | Prospective, randomised, placebo-controlled, double blind, single centre, parallel design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PADI |
| Study hypothesis | Gastrointestinal flora abnormal in infants with atopic dermatitis (defective Th1/2 regulation). The abnormality can be corrected by probiotic supplementation. |
| Ethics approval(s) | Yes - 24/10/2001 - ref: 01/320 |
| Condition | Atopic dermatitis |
| Intervention | Randomised placebo controlled trial to study the effect of supplementing infants diet with either Bifidobacterium lactis or Lactobacillus paracasei. Comparisons: 1. Bifidobacterium versus Lactobacillus 2. Bifidobacterium versus Placebo 3. Lactobacillus versus Placebo All randomised infants on dairy free diet. Open observational groups (exclusively breastfed, standard formula fed = not for formal hypothesis testing). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bifidobacterium lactis, Lactobacillus paracasei |
| Primary outcome measure | The primary outcome measure is the change in SCORAD index from the beginning of study treatment to the end of the treatment phase, week 12. |
| Secondary outcome measures | 1. The administration of probiotics to infants resulting in colonisation of the gastrointestinal tract will be investigated by Polymerase Chain Reaction (PCR) examination of stool specimens before, during and after administration 2. Blood will be taken at randomisation (week 0) and at week 12 for measurement of total and specific Immunoglobulin E (IgE) and Eosinophil Cationic Protein (ECP) 3. Stool Tumour Necrotising Factor-alpha (TNFα) will be measured at week 0, at week 12 and at age 1 year 4. Subjects will be reviewed at age 1 year, when SCORAD scores and information regarding history of wheeze will be sought 5. Infants will be weighed and measured at each visit, and plotted on a growth chart (UK cross-sectional reference data: 1996/1, child growth foundation) 6. All adverse events (minor and serious) |
| Overall study start date | 01/03/2002 |
| Overall study end date | 30/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 250 |
| Participant inclusion criteria | 1. Age 3 - 6 months 2. Be within the 2nd and 98th centiles for weight (ref: UK cross-sectional data 1996:1) 3. Have a physician diagnosis of atopic dermatitis 4. SCORing Atopic Dermatitis (SCORAD) score greater than 10 at visit 1 |
| Participant exclusion criteria | 1. Preterm, born before 34 weeks gestation 2. Congenital abnormality or suffering from a chronic disease such as: cystic fibrosis, immune deficiency or malabsorption syndrome 3. Currently taking antibiotics 4. Already using a soya or hydrolysed formula |
| Recruitment start date | 01/03/2002 |
| Recruitment end date | 30/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NWLRC
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Wythenshawe Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
| Phone | +44 (0)161 291 5775 |
|---|---|
| amaines@fs1.with.man.ac.uk | |
"ROR" |
https://ror.org/05vpsdj37 |
Funders
Funder type
Industry
Nestec Ltd (UK) (ref: 01.19.NRC)
No information available
North West Lung Research Centre Endowment Fund (UK) - c/o Professor Woodcock
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
