Condition category
Skin and Connective Tissue Diseases
Date applied
27/10/2005
Date assigned
28/11/2005
Last edited
01/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Murray

ORCID ID

Contact details

NWLRC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 4199

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01.19.NRC

Study information

Scientific title

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

Yes - 24/10/2001 - ref: 01/320

Study design

Prospective, randomised, placebo-controlled, double blind, single centre, parallel design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Bifidobacterium lactis, Lactobacillus paracasei

Primary outcome measures

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 trial start date

01/03/2002

Overall trial end date

30/05/2004

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

250

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

United Kingdom

Trial participating centre

NWLRC
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Wythenshawe Hospital (UK)

Sponsor details

Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5775
amaines@fs1.with.man.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Nestec Ltd (UK) (ref: 01.19.NRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North West Lung Research Centre Endowment Fund (UK) - c/o Professor Woodcock

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22092692

Publication citations

  1. Results

    Gore C, Custovic A, Tannock GW, Munro K, Kerry G, Johnson K, Peterson C, Morris J, Chaloner C, Murray CS, Woodcock A, Treatment and secondary prevention effects of the probiotics Lactobacillus paracasei or Bifidobacterium lactis on early infant eczema: randomized controlled trial with follow-up until age 3 years., Clin. Exp. Allergy, 2012, 42, 1, 112-122, doi: 10.1111/j.1365-2222.2011.03885.x.

Additional files

Editorial Notes