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Trial registered on ANZCTR
Registration number
ACTRN12608000594325
Ethics application status
Approved
Date submitted
31/10/2008
Date registered
25/11/2008
Date last updated
13/07/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy
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Scientific title
Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy
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Secondary ID [1]
252052
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
P-POIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peanut allergy
3872
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Condition category
Condition code
Inflammatory and Immune System
4069
4069
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Lactobacillus rhamnosus GG (LGG) and Peanut Oral Immunotherapy
LGG - 1 scoop delivering 2x10E10 Colony-forming units (cfu) of LGG taken once daily for 18 months dissolved into water, soy or cow’s milk, at a temperature NOT exceeding 45 °C
Peanut Oral Immunotherapy (OIT) - In the modified rush phase, subjects will receive increasing doses of peanut oral immunotherapy, starting at 0.1mg peanut protein with doubling of the dosage every 30 minutes to reach a final dose of 12mg of peanut protein (in total 8 doses delivered in 1 day, with a cumulative dose of 24mg peanut protein). In the buildup phase, the daily dose of peanut OIT will start at 24mg peanut protein and will be increased every 2 weeks until a maintenance dose of 2g is reached (expected to take 8 months). Dosage increments are as follows :- 24mg, 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 200mg, 260mg, 330mg, 425mg, 550mg, 715mg, 925mg, 1.2g, 1.55g and 2g. If mild allergic symptoms develop (urticaria, angioedema, vomiting, abdominal pain), the dose is repeated before increasing. If moderate/severe allergic symptoms occur (stridor, wheeze) the dose will be reduced by 25% before proceeding. If severe anaphylaxis develops (reduced BP, loss of consciousness) OIT will be discontinued. The dose is maintained at 2g for about 10 months, but will be shorter for subjects who take longer to reach maintenance dose. Peanut oral immunotherapy will administered orally in all phases with the peanut protein sprinkled and mixed into yoghurt. The overall duration of the intervention is 18 months.
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Intervention code [1]
3599
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Treatment: Other
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Comparator / control treatment
OIT placebo is maltodextrin, a glucose polymer mixed with peanut flavour and powdered brown food colouring so it looks, tastes and smells like the peanut product. OIT placebo will be given in exactly the same amount and frequency and for the same duration as the peanut protein as described above and will be administered orally, sprinkled and mixed into yoghurt.
The probiotic placebo will be maltodextrin, administered as 1 scoop once daily for 18 months (the same amount, frequency and duration as the treatment group) dissolved into water, soy or cow’s milk, at a temperature NOT exceeding 45 °C.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To examine whether combined treatment with probiotic and peanut OIT (P-POIT) in children with peanut allergy will induce tolerance to peanut in a greater proportion of children compared with placebo, where tolerance is defined as the ability to tolerate 8g of peanut protein in an oral peanut challenge performed 2 to 12 weeks after discontinuation of P-POIT (in those who pass the first challenge on the last day of P-POIT)
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Assessment method [1]
4969
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Timepoint [1]
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2-12 weeks after discontinuation of P-POIT
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Secondary outcome [1]
8384
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To examine whether combined treatment with probiotic and peanut OIT (P-POIT) in children with peanut allergy will result in desensitisation to peanut in a greater proportion of children compared with placebo, where desensitisation is defined as the ability to tolerate >2g of peanut protein in an oral peanut challenge performed on the last day of oral immunotherapy.
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Assessment method [1]
8384
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Timepoint [1]
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On day of discontinuation of P-POIT.
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Secondary outcome [2]
8385
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To examine the effects of combined treatment with probiotic and peanut OIT (P-POIT) or placebo on serum levels of peanut specific Immunoglobulin E (IgE) and peanut specific Immunoglobulin G4 (IgG4). and salivary levels of peanut specific Immunoglobulin A (IgA) in children with peanut allergy. IgE will be measured by Capsulated Hydrophobic Carrier Polymer- Radioallergosorbent Test (CAP-RAST) in our laboratory using the UNICAP system (Pharmacia Diagnostics). IgG4 and IgA will be measures by Enzyme-Linked ImmunoSorbent Assay (ELISA) at our collaborator, Wesley Burks' lab in Duke University Medical Centre, USA.
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Assessment method [2]
8385
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Timepoint [2]
8385
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4, 8, 12, 18, 22 and 23 months
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Secondary outcome [3]
8386
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To examine the effects of combined treatment with probiotic and peanut OIT (P-POIT) or placebo on peripheral blood T regulatory cell (Treg) and dendritic cell (DC) populations and T helper 1 and T helper 2 cytokine production.
Mononuclear cells (MNC) will be separated from heparinised blood by density gradient centrifugation within 8 hours and cryopreserved (20x10E6cells/ml) at each timepoint. Treg and DC populations will be assessed by flow cytometry in freshly thawed and cultured MNC stimulated with anti-CD3, Ara h 2, crude peanut extract or tetanus antigens.
Treg will be identified as CD3+CD4+CD25hiCD127lo cells and CD3+CD4+CD25hiFoxp3+ cells. Proliferating CD4+ cells will be identified by reduced Carboxyfluorescein succinimidyl ester (CFSE) staining and antigen specific Treg will be identified within this population by staining for Foxp3+ or CD127lo cells.
DC will be assessed by flow cytometry - plasmacytoid dendritic cells (pDC) and myeloid dendritic cells (mDC) will be identified as CD11cloCD123whi or CD11chiCD123wlo cells within the lineage-/HLADR+ cell population, respectively.
T helper and Treg cytokines will be assessed in MNC cultures stimulated with PHA, anti-CD3, tetanus toxoid, crude peanut extract, Ara h 2 or media alone at each timepoint. IFN?, IL4, IL13, TGF-beta and IL10 will be assayed by multiplex array.
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Assessment method [3]
8386
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Timepoint [3]
8386
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4, 8, 12, 18, 22 and 23 months
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Secondary outcome [4]
336881
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To examine whether combined treatment with probiotic and peanut OIT (P-POIT) in children with peanut allergy will induce long-term tolerance to peanut in a greater proportion of children compared with placebo, where long-term tolerance is defined as the ability to tolerate 4g of peanut protein in an oral peanut challenge performed 3-4 years after discontinuation of OIT.
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Assessment method [4]
336881
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Timepoint [4]
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3-4 years after discontinuation of OIT.
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Eligibility
Key inclusion criteria
Children are eligible for the study if they:
1) Are aged between 1 year and 10 years of age
2) Are above 10kg
3) There is a confirmed diagnosis of peanut allergy as defined by:
-a positive food challenge to peanut in the past 2 years AND a positive skin prick test (SPT) or Capsulated Hydrophobic Carrier Polymer- Radioallergosorbent Test (CAP-RAST) to peanut
OR
-a positive food challenge or history of reaction to peanut ever AND a positive SPT greater than or equal to 8mm or a CAP-RAST greater than or equal to 15KU/l to peanut
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Minimum age
1
Years
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Maximum age
10
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children will not be eligible for the study if they have a history of:
1) severe anaphylaxis (as defined by hypotension , collapse, loss of consciousness or hypoxia)
2) Forced Expiratory Volume in 1 Second (FEV1) of <85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
3) Underlying medical conditions (eg cardiac disease) that increase the risks associated with anaphylaxis
4) Known wheat allergy (the placebo may contain traces of wheat)
5) Use of beta-blockers
6) Inflammatory intestinal conditions, indwelling catheters, gastrostomies or other conditions that may increase the risks of probiotic associated sepsis
7) Cow’s milk allergy, as there may be traces of cow’s milk in the probiotic preparation
8) Already taking probiotics
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All screened subjects will be given a screening number and if deemed eligible, will be assigned a study number. This study number will correspond to a number on a computer-generated list to determine which treatment arm the subject is assigned to. This list will be generated at the hospital's Biostatistics Unit and delivered to the Pharmacy Department in a sealed opaque envelope.
Peanut/placebo product is concealed in coloured sachets and only the Pharmacy Department has the codes to unblind the the product.
Probiotic/placebo product is concealed in tins which have been randomized by the supplier (Nestle) and the randomization code was sealed in an opaque envelope and mailed directly to the Pharmacy Department.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be from a computer-generated list of random numbers in short permuted blocks prepared by the Clinical Epidemiology and Biostatistics Unit (CEBU) in the Royal Children's Hospital (RCH) and will be used by the Pharmacy department to distribute oral immunotherapy and probiotic treatments.
Randomisation will be stratified by: 1) age 5 years or less and 6 years or older; and 2) skin prick test (SPT) wheal size 10mm or less and greater than 10mm.
The nurse delivering the oral immunotherapy will not know which intervention arm of the study the patient is in – i.e. the study will be double blind.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We aim to recruit 90 subjects. N=38 in each group provides greater than 80% power to detect the difference between a 4% rate of tolerance in the placebo group and a 30% rate of tolerance in the treatment group, using a 2 group continuity corrected chi-square test with a 0.05 two sided significance level. Allowing for 15% participant loss, n=45 in each group will be recruited. We will perform intention to treat analysis, and logistic regression with adjustment for potential confounders.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2008
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Actual
2/12/2008
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Date of last participant enrolment
Anticipated
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Actual
22/02/2011
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Date of last data collection
Anticipated
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Actual
2/02/2016
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Sample size
Target
90
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
4054
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Charities/Societies/Foundations
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Name [1]
4054
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Food Allergy and Anaphylaxis Network (FAAN)
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Address [1]
4054
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11781 Lee Jackson Hwy., Suite 160
Fairfax, VA 22033-3309
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Country [1]
4054
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United States of America
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Funding source category [2]
4055
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Commercial sector/Industry
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Name [2]
4055
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Macquarie Bank Foundation
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Address [2]
4055
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No 1 Martin Place
Sydney NSW 2000
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Country [2]
4055
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Australia
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Funding source category [3]
257154
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Other
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Name [3]
257154
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Murdoch Children's Research Institute
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Address [3]
257154
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FLemington Rd, Parkville, VIC 3052
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Country [3]
257154
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Australia
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Funding source category [4]
295798
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Charities/Societies/Foundations
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Name [4]
295798
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Financial Markets Foundation for Children
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Address [4]
295798
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GPO Box 3655
Sydney NSW 2000
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Country [4]
295798
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Australia
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Funding source category [5]
295799
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Charities/Societies/Foundations
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Name [5]
295799
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Jack Brockhoff Foundation
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Address [5]
295799
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501/685 Burke Road
Camberwell VIC 3124
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Country [5]
295799
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Australia
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Funding source category [6]
295800
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Charities/Societies/Foundations
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Name [6]
295800
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Perpetual Philanthropy
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Address [6]
295800
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GPO Box 4172, Sydney NSW 2000
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Country [6]
295800
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Australia
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Funding source category [7]
295801
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Charities/Societies/Foundations
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Name [7]
295801
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CASS Foundation
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Address [7]
295801
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Level 2, 111 Collins Street
Melbourne Victoria 3000
Australia
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Country [7]
295801
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Australia
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Funding source category [8]
295802
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Government body
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Name [8]
295802
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National Health and Medical Research Council
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Address [8]
295802
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GPO Box 1421
Canberra ACT 2601
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Country [8]
295802
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Australia
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Primary sponsor type
Hospital
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Name
Royal Children's Hospital
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Address
Royal Children's Hospital
Flemington Road,
Parkville Vic. 3052
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Country
Australia
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Secondary sponsor category [1]
3650
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Other Collaborative groups
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Name [1]
3650
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Murdoch Children's Research Institute
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Address [1]
3650
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Royal Children's Hospital
Flemington Road,
Parkville Vic. 3052
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Country [1]
3650
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6132
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RCH Human Research Ethics Committee
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Ethics committee address [1]
6132
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Royal Children's Hospital
Flemington Road, Parkville
Victoria 3052
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Ethics committee country [1]
6132
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Australia
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Date submitted for ethics approval [1]
6132
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Approval date [1]
6132
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11/08/2008
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Ethics approval number [1]
6132
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27086
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Summary
Brief summary
A two arm randomised-controlled trial to test a novel therapy (Peanut Oral Immunotherapy with a Probiotic adjunct) against placebo. The findings of this study will provide much needed evidence on whether OIT combined with a probiotic adjunct can induce tolerance in children with peanut allergy.
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Trial website
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Trial related presentations / publications
Primary outcome data have been published - MLK Tang, AL Ponsonby, F Orsini, D Tey, M Robinson, EL Su, P Licciardi, W Burks, S Donath. Administration of probiotic with peanut oral immunotherapy, a randomized trial. J Allergy Clin Immunol 2015;135:737-44.
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Public notes
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Contacts
Principal investigator
Name
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Prof Mimi Tang
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Address
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Royal Children's Hospital
Department of Allergy and Immunology
Flemington Rd
Parkville VIC 3052
Australia
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Country
29070
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Australia
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Phone
29070
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+61 3 9345 5733
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Fax
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Email
29070
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[email protected]
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Contact person for public queries
Name
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Prof Prof Mimi Tang
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Address
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Department of Allergy and Immunology
Royal Children's Hospital
Flemington Road,
Parkville Vic. 3052
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Country
12227
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Australia
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Phone
12227
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+61 3 9345 5733
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Fax
12227
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+61 3 9345 4848
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Email
12227
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[email protected]
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Contact person for scientific queries
Name
3155
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Prof Prof Mimi Tang
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Address
3155
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Department of Allergy and Immunology
Royal Children's Hospital
Flemington Road,
Parkville Vic. 3052
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Country
3155
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Australia
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Phone
3155
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+61 3 9345 5733
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Fax
3155
0
+61 3 9345 4848
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Email
3155
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Longitudinal antibody responses to peanut following probiotic and peanut oral immunotherapy in children with peanut allergy.
2022
https://dx.doi.org/10.1111/cea.14146
Embase
Microbiome Therapeutics for Food Allergy.
2022
https://dx.doi.org/10.3390/nu14235155
Embase
Long-term benefit of probiotic peanut oral immunotherapy on quality of life in a randomized trial.
2021
https://dx.doi.org/10.1016/j.jaip.2021.07.047
Dimensions AI
Remission of peanut allergy is associated with rewiring of allergen-driven T helper 2-related gene networks
2022
https://doi.org/10.1111/all.15324
N.B. These documents automatically identified may not have been verified by the study sponsor.
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