Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Randomised placebo controlled trial to study the effect of supplementing infants? diet with either Bifidobacterium lactis or Lactobacillus paracasei.
Comparisons:
1. Bifidobacterium versus Lactobac
Sponsors
Wythenshawe Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 (TNFa) 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) | — |
Countries
United Kingdom
Outcome results
None listed