Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZG/2/277
Study information
Scientific title
Investigating the effectiveness of primary prevention strategies using extensively hydrolysed milk formula and probiotic supplements to prevent allergic disease in high risk infants: pilot factorial randomised controlled trial
Acronym
Study hypothesis
The primary aim of this pilot study is to test the feasibility of administering an extensively hydrolysed milk formula, with either a placebo probiotic or probiotic, to mothers with infants at high risk of atopic disease in Scotland and compare the likely uptake and effectiveness of these interventions using a factorial randomised controlled trial. This study will inform a definitive large-scale multi-centre double blind placebo randomised controlled trial.
As of 10/04/2012, the anticipated end date of trial was updated from 31/12/2008 to 31/10/2008.
Ethics approval
Ethics approval pending from the Lothian Ethics Committee as of 13/02/2008.
Study design
Feasibility study: 2 x 2 factorial randomised controlled design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Atopic disease: asthma, atopic dermatitis, allergic rhinitis or food allergy
Intervention
1. Probiotic or placebo probiotic: one sachet of probiotic to be mixed with 1 ml of water, taken once daily
2. Normal milk formula or extensively hydrolysed milk formula: study formula to be taken as needed
The total duration of treatment will be six months, and the total duration of follow-up for all treatment arms will be six months. The three and six month assessments will take up to one hour.
Intervention type
Drug
Phase
Not Specified
Drug names
Milk formula, probiotic
Primary outcome measures
1. Recruitment rate, i.e., what proportion of those invited agree to participate, measured at three months
2. Retention rate, i.e., what proportion of those enrolled complete the study, measured at the end of the study
3. Acceptability of interventions to mothers, measured at three and six month assessment
4. Parental reports of acceptability of interventions to infants, measured at three and six month assessment
5. Incidence and severity of atopic eczema at 3 and 6 months
6. Acceptability to midwives, health workers and paediatric nurse, measured at nine months
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/04/2008
Overall trial end date
31/10/2008
Reason abandoned
"Objectives no longer viable"
Eligibility
Participant inclusion criteria
1. Infants at high risk of atopy as judged by the mother, father or sibling having an allergic disease (asthma, allergic rhinitis, atopic dermatitis and food allergy)
2. Booked to give birth at the Royal Infirmary, Edinburgh
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
36
Participant exclusion criteria
1. Do not give informed consent
2. Multiple pregnancy
3. Delivering prior to 37 weeks gestation
Recruitment start date
01/04/2008
Recruitment end date
31/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Community Health Sciences: GP Section
Edinburgh
EH8 9DX
United Kingdom
Sponsor information
Organisation
Chief Scientist Office (UK)
Sponsor details
St Andrews House
Edinburgh
ED1 3DG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (UK) (ref: CZG/2/277)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
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