Condition category
Signs and Symptoms
Date applied
13/02/2008
Date assigned
27/02/2008
Last edited
10/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Aziz Sheikh

ORCID ID

Contact details

Division of Community Health Sciences: GP Section
The University of Edinburgh
Levinson House
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom

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

http://www.sehd.scot.nhs.uk/cso/

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

Publication citations

Additional files

Editorial Notes