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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00424386

Enrollment

Registered

2008-02-27

Start date

2008-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic disease: asthma, atopic dermatitis, allergic rhinitis or food allergy Signs and Symptoms Atopic disease

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Do not give informed consent 2. Multiple pregnancy 3. Delivering prior to 37 weeks gestation

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026