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Trial registered on ANZCTR


Registration number
ACTRN12614000635662
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
17/06/2014
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of whey proteins for the treatment of atopic dermatitis: A pilot study.
Scientific title
Effectiveness of Glycomax 'trademark' Lactoferrin and bovine whey-derived Ig-rich fraction for the treatment of atopic dermatitis: A pilot study
Secondary ID [1] 284732 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 292086 0
Condition category
Condition code
Skin 292426 292426 0 0
Dermatological conditions
Inflammatory and Immune System 292516 292516 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily oral supplementation for 56 days with a combined 250mg each of bovine whey derived Glycomax 'trademark' lactoferrin and bovine whey-Ig rich fraction or a Placebo, both in tablet form.

Each participant will also be provided with a hypoallergenic sorbolene cream (Dermeze Sensitive Cream) for the relief of dryness as required at their discretion.

Supplements and the Dermeze cream will be collected at the end of the study for assessing adherence.
Intervention code [1] 289515 0
Treatment: Other
Comparator / control treatment
Placebo supplement (mannitol and calcium carbonate based tablets) in tablet form.
Control group
Placebo

Outcomes
Primary outcome [1] 292287 0
The severity of eczema symptoms measured by SCORAD (SCORing Atopic Dermatitis). SCORAD is a clinical tool used to assess the extent and severity of eczema. It is validated for determining severity of eczema and will be utilised by a consultant dermatologist.
Timepoint [1] 292287 0
Scoring will occur at baseline and then every two weeks for eight weeks (day 56) followed by further assessment four weeks after supplementation
Secondary outcome [1] 308639 0
PO-SCORAD: The Patient Orientated SCORAD is a tool to self-evaluate atopic dermatitis.
Timepoint [1] 308639 0
PO-SCORAD will be undertaken at baseline and then every two weeks during a clinic visit for eight weeks (day 56 of supplementation) and then four weeks following the end of supplementation.
Secondary outcome [2] 308640 0
Skin dermatographism test: This clinical test involves applying physical pressure (scratch) to determine if an allergic-like reaction occurs (dermatographism). Symptoms of dermatographism, a rare skin condition, are thought to be caused by mast cells in the surface of the skin releasing histamines without the presence of antigens, causing the skin to swell in the affected areas. The weak membrane of the mast cells easily and rapidly breaks down under physical pressure causing an allergic-like reaction, in general a red weal (welt) to appear on the skin. This simple test will be performed by a clinician or nurse.
Timepoint [2] 308640 0
The skin dermatographism test will be undertaken at baseline, week 8 (end of supplementation) and four weeks following the cessation of supplementation.
Secondary outcome [3] 308641 0
Full blood count and white cell differential. Cell count will be done on a routine haematology analyser at a pathology laboratory.
Timepoint [3] 308641 0
Blood will be drawn at baseline, week 2, Week 4, week 6, week 8 and week 12.
Secondary outcome [4] 308642 0
Blood and skin CD4+T cell subsets determined by flow cytometry.
Timepoint [4] 308642 0
A blood sample and a skin biopsy will be collected at baseline, week 8 (end of supplementation) and four weeks following cessation of supplementation.
Secondary outcome [5] 308643 0
Serum inflammatory markers, including C-reactive protein, erythrocyte sedimentation rate, IgE, and Th17 cytokines (IL-1beta, IL-4, lL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-gamma, sCD40L, TNF-a, IL-17A/F (singleplex only). The markers will be determined by immunoassay or bead array.
Timepoint [5] 308643 0
Blood samples will be collected at baseline, week 4, week8 and week 12.

Eligibility
Key inclusion criteria
Presence of atopic dermatitis according to physician diagnosis using SCORAD
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 is lactose intolerant
2 consumes fish oil, probiotics, prebiotics, whey protein supplements during the trial period
3 requires insulin use (for treatment of diabetes)
4 has history of liver, kidney or thyroid disease
5 uses anti-inflammatory or immune-modulating medications
6 has heavy alcohol consumption
7 is pregnant or intends to become pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomly allocated. Allocation will be concealed as eligibility will be undertaken prior to allocation and the individual conducting the allocation procedure will be independent to those assessing for eligibility. Subjects will also be assigned to groups identified by code that does not reveal the group to which the person was assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be conducted through a simple randomisation computer-based program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
As a pilot study this will have 30 participants in the treatment arm and 15 participants in the control arm
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The approach will be a repeated measures within group analysis to ascertain the mean effect and 95% confidence intervals of the intervention. Effects in the placebo group will be used to examine underlying changes in the severity of eczema over the study period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2014
Actual
19/06/2014
Date of last participant enrolment
Anticipated
5/06/2015
Actual
28/08/2015
Date of last data collection
Anticipated
Actual
13/11/2015
Sample size
Target
45
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8288 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 289387 0
Commercial sector/Industry
Name [1] 289387 0
Probiotec Pharma Pty Lttd
Country [1] 289387 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Kessels Road, Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 288073 0
Commercial sector/Industry
Name [1] 288073 0
Probiotec Pharma Pty Ltd
Address [1] 288073 0
83 Cherry Lane, Laverton North, Victoria 3026
Country [1] 288073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291150 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291150 0
Ethics committee country [1] 291150 0
Australia
Date submitted for ethics approval [1] 291150 0
Approval date [1] 291150 0
18/03/2014
Ethics approval number [1] 291150 0
MED/09/14/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48934 0
Prof Allan Cripps
Address 48934 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 48934 0
Australia
Phone 48934 0
+61 7 5678 0809
Fax 48934 0
Email 48934 0
allan.cripps@griffith.edu.au
Contact person for public queries
Name 48935 0
Nicholas west
Address 48935 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 48935 0
Australia
Phone 48935 0
61419649447
Fax 48935 0
Email 48935 0
n.west@griffith.edu.au
Contact person for scientific queries
Name 48936 0
Nicholas west
Address 48936 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 48936 0
Australia
Phone 48936 0
61419649447
Fax 48936 0
Email 48936 0
n.west@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOral supplementation with bovine whey-derived Ig-rich fraction and lactoferrin improves SCORAD and DLQI in atopic dermatitis.2017https://dx.doi.org/10.1016/j.jdermsci.2016.11.009
N.B. These documents automatically identified may not have been verified by the study sponsor.