| Source of record | UK Trials |
| ISRCTN | ISRCTN00424386 |
| Date ISRCTN assigned | 27/02/2008 |
| Local reference number(s) | CZG/2/277 |
| Public title | Feasibility randomised controlled trial: probiotics and milk formula to prevent allergic disease |
| 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 | N/A |
| Disease/condition/study domain | Atopic disease: asthma, atopic dermatitis, allergic rhinitis or food allergy |
| 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. |
| Design/methodology | Feasibility study: 2 x 2 factorial randomised controlled design |
| Research ethics review | Ethics approval pending from the Lothian Ethics Committee as of 13/02/2008. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | 1. Do not give informed consent
2. Multiple pregnancy
3. Delivering prior to 37 weeks gestation |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 36 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration. |
| Sources of funding | Chief Scientist Office (UK) (ref: CZG/2/277) |
| Sponsor name | Chief Scientist Office (UK) |
| Sponsor details | St Andrews House
Edinburgh
United Kingdom
ED1 3DG |
| Sponsor website | http://www.sehd.scot.nhs.uk/cso/ |
| Contact name | Prof Aziz Sheikh |
| Contact details | Division of Community Health Sciences: GP Section
The University of Edinburgh
Levinson House
20 West Richmond Street
Edinburgh
United Kingdom
EH8 9DX |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN00424386 |
| Date last extracted from ISRCTN register | 17/04/2008 |
