Feasibility randomised controlled trial: probiotics and milk formula to prevent allergic disease

ISRCTN ISRCTN00424386
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

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 designFeasibility study: 2 x 2 factorial randomised controlled design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInvestigating 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 objectivesThe 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) studiedAtopic disease: asthma, atopic dermatitis, allergic rhinitis or food allergy
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Milk formula, probiotic
Primary outcome measure1. 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 measuresNot provided at time of registration.
Overall study start date01/04/2008
Completion date31/10/2008
Reason abandoned (if study stopped)"Objectives no longer viable"

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants36
Key inclusion criteria1. 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 criteria1. Do not give informed consent
2. Multiple pregnancy
3. Delivering prior to 37 weeks gestation
Date of first enrolment01/04/2008
Date of final enrolment31/10/2008

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Division of Community Health Sciences: GP Section
Edinburgh
EH8 9DX
United Kingdom

Sponsor information

Chief Scientist Office (UK)
Government

St Andrews House
Edinburgh
ED1 3DG
United Kingdom

Website http://www.sehd.scot.nhs.uk/cso/
ROR logo "ROR" https://ror.org/01bw7zm61

Funders

Funder type

Government

Chief Scientist Office (UK) (ref: CZG/2/277)
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan