Feasibility randomised controlled trial: probiotics and milk formula to prevent allergic disease
ISRCTN | ISRCTN00424386 |
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DOI | https://doi.org/10.1186/ISRCTN00424386 |
Secondary identifying numbers | CZG/2/277 |
- Submission date
- 13/02/2008
- Registration date
- 27/02/2008
- Last edited
- 10/04/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Aziz Sheikh
Scientific
Scientific
Division of Community Health Sciences: GP Section
The University of Edinburgh
Levinson House
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom
Study information
Study design | Feasibility study: 2 x 2 factorial randomised controlled design |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | Ethics approval pending from the Lothian Ethics Committee as of 13/02/2008. |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Milk formula, probiotic |
Primary outcome measure | 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 study start date | 01/04/2008 |
Completion date | 31/10/2008 |
Reason abandoned (if study stopped) | "Objectives no longer viable" |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 36 |
Key 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 |
Key exclusion criteria | 1. Do not give informed consent 2. Multiple pregnancy 3. Delivering prior to 37 weeks gestation |
Date of first enrolment | 01/04/2008 |
Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Division of Community Health Sciences: GP Section
Edinburgh
EH8 9DX
United Kingdom
EH8 9DX
United Kingdom
Sponsor information
Chief Scientist Office (UK)
Government
Government
St Andrews House
Edinburgh
ED1 3DG
United Kingdom
Website | http://www.sehd.scot.nhs.uk/cso/ |
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https://ror.org/01bw7zm61 |
Funders
Funder type
Government
Chief Scientist Office (UK) (ref: CZG/2/277)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |