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

ISRCTN	ISRCTN00424386
DOI	https://doi.org/10.1186/ISRCTN00424386
Protocol serial number	CZG/2/277
Sponsor	Chief Scientist Office (UK)
Funder	Chief Scientist Office (UK) (ref: 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

Primary study design	Interventional
Study design	Feasibility study: 2 x 2 factorial randomised controlled design
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Milk formula, probiotic
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
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/10/2008
Reason abandoned (if study stopped)	"Objectives no longer viable"

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

United Kingdom
Scotland

Study participating centre

Division of Community Health Sciences: GP Section

Edinburgh
EH8 9DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes