The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
PEBBLES
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
2 other identifiers
interventional
760
1 country
4
Brief Summary
This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of three hospitals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2018
CompletedFirst Submitted
Initial submission to the registry
September 9, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
May 10, 2023
May 1, 2023
9.2 years
September 9, 2018
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Presence of eczema
as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.
12 months of age.
Confirmed diagnosis of food allergy at 12 months (52 weeks).
This diagnosis is derived from a combination of allergic sensitisation, reaction history and food challenge. A skin prick test to six common allergens will be performed (egg white, cows' milk, peanut, dust mite, cat dander, and rye grass) along with a negative (saline) and a positive (histamine) control. Participants that are sensitised to certain foods (\>=1mm wheal) during the skin prick testing will be given a challenge to determine if they are allergic to those foods. This will be conducted at the MCRI Allergy Clinic under the supervision of a Doctor specifically trained in oral food challenges.
12 months of age
Secondary Outcomes (6)
Eczema severity
12 months of age
Parent report of a community doctor diagnosis of eczema
12 months of age
infant skin barrier function
At 6 weeks and 12 months of age
Parental compliance with a program to build infant skin barrier function
At 6 weeks and 6 months of age.
Adverse events
From recruitment of infant until final study visit at 12 months of age.
- +1 more secondary outcomes
Study Arms (2)
Twice daily use treatment with EpiCeram
ACTIVE COMPARATORThey will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for 6 months. The prophylactic use of EpiCeram™ is the intervention that is being tested for its effect on infant skin barrier function. We will instruct parents to apply approximately 6 grams of EpiCeram™ per application at two regular times each day, including after bathing the infant, or at the time they would normally bathe their child.
Standard skin care
NO INTERVENTIONParents are to follow standard skin care practices
Interventions
Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.
Eligibility Criteria
You may qualify if:
- Infants will be eligible for this study if their mother, father, or an older sibling has a self-reported history of at least one of the following conditions:
- asthma,
- eczema/atopic dermatitis,
- hay fever/ allergic rhinitis or
- food allergy
You may not qualify if:
- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram™ will be excluded, as it would be difficult for these parents to apply EpiCeram™ to their infant, and there is likely to be an increased risk of the infant reacting to the cream.
- Multiple births (twins, triplets etc.) will be excluded, due to the difficulty in randomising individual twins and because of the clustering effect of multiple children from the same family which would reduce the effective sample size of the study.
- Who are born premature (\<36 weeks) as the effect of the intervention may be different in premature infants.
- Who have major birth or early life medical complications that require admission into a special care nursery, as it will be difficult for parents to comply with the study requirements.
- Whose parents do not have sufficient English language skills to be able to answer questions.
- Whose parents are not able to comply with all protocol required visits and procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Mercy Women's Hospital
Heidelberg, Victoria, 3084, Australia
Frances Perry Private Hospital
Parkville, Victoria, 3052, Australia
Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
Royal Women's Hospital
Parkville, Victoria, 3052, Australia
Related Publications (1)
Lowe A, Su J, Tang M, Lodge CJ, Matheson M, Allen KJ, Varigos G, Sasi A, Cranswick N, Hamilton S, Robertson CF, Hui J, Abramson M, O'Brien S, Dharmage S. PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy. BMJ Open. 2019 Mar 13;9(3):e024594. doi: 10.1136/bmjopen-2018-024594.
PMID: 30867201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian J Lowe, Doctorate
University of Melbourne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor will be blinded to the group of allocation and will have no contact with the participants aside from the assessment of outcomes at six-weeks and 12-months
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Adrian Lowe
Study Record Dates
First Submitted
September 9, 2018
First Posted
September 12, 2018
Study Start
March 6, 2018
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
May 10, 2023
Record last verified: 2023-05