Probiotics in Atopic Dermatitis in Infancy
| ISRCTN | ISRCTN41490500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41490500 |
| Protocol serial number | 01.19.NRC |
| Sponsor | Wythenshawe Hospital (UK) |
| Funders | Nestec Ltd (UK) (ref: 01.19.NRC), North West Lung Research Centre Endowment Fund (UK) - c/o Professor Woodcock |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
NWLRC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 4199 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, placebo-controlled, double blind, single centre, parallel design |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PADI |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bifidobacterium lactis, Lactobacillus paracasei |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 6 Months |
| Sex | All |
| Target sample size at registration | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 30/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
