Trial phase Screening
(pre-trial)
Randomisation and RUSH day Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
Week 78+ DBPCFC
(minimum of 6 months maintenance)
Post treatment 1 clinic visit
(2 – 6 weeks after T1 DBPCFC)
Post treatment 2 clinic visit
(3 months after T1 DBPCFC)
Post treatment 3 phone interview
(6 months after T1 DBPCFC)
Post treatment 4 clinic visit
(12 months after T1 DBPCFC)
Post treatment 5 clinic visit
(3-4 years after T1 DBPCFC)
Follow up phone/email questionnaires
(every 6 months)
Final email/phone follow up
(3 years after T5)
Time point RUSH / T0 T1 T2 T3 T4 T5
Month of study (minimum) 0 0 1-8 9-18 18 > 18.5 > 21 > 24 > 30 > 54-66 > 60-96 > 90-102
Randomisation X
Oral immunotherapy/placebo (RUSH) X 1
Probiotic/placebo dispensed X X X
Oral immunotherapy/placebo dispensed X X X
Intervention compliance review
(every clinic visit during build
up and maintenance)
P:SDV P:SDV
Diary review
(every clinic visit during build
up and maintenance)
P:SDV P:SDV P:SDV
Adverse events and con med review
(every clinic visit during build
up and maintenance)
P:SDV P:SDV P:SDV P:SDV
Oral double blind placebo
controlled food challenge
O:DBPCFC
PPOIT:13
Placebo:11
(optional)
O:DBPCFC
PPOIT: 29
Placebo: 28
O:DBPCFC
PPOIT: 25
Placebo: 2
(if passed at T1)
O:DBPCFC
PPOIT: 12
Placebo: 15
(optional)
Skin prick test O:SPT O:SPT O:SPT O:SPT O:SPT
PPOIT: 19
Placebo: 19
(optional)
Peanut allergen exposure
during breastfeeding
(maternal peanut consumption and
use of creams containing peanut oil)
P:PAQ M P:PAQ M
(week 17)
P:PAQ M
(first maintenance visit, week 49)
P:PAQ M P:PAQ M P:PAQ M
Use of creams containing peanut oil
(on child)
P:PAQ P:PAQ
(week 17)
P:PAQ
(first maintenance visit, week 49)
P:PAQ P:PAQ P:PAQ
Allergic reaction history – peanut P:PAQ P:PAQ
(week 17)
P:SDV
P:PAQ
(first maintenance visit, week 49)
P:PAQ P:PAQ P:PAQ P:SDV P:SDV
Trial phase Sc
Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
T2
(final day of study treatment)
T3
(8 weeks after end of study treatment)
T4
(1 year after end of study treatment)
T5
(3 years after end of study treatment)
Month of study 0 0 1-4 5-18 18 20 30 54
Oral immunotherapy (RUSH) X 1
Intervention compliance review
(every clinic visit during build up
and every 12 weeks during maintenance)
P:SDV P:SDV
Diary review
(every clinic visit during build up
and every 12 weeks during maintenance)
P:SDV P:SDV
Adverse events and medication review
(every clinic visit during build up
and every 12 weeks during maintenance)
P:SDV P:SDV P:SDV P:SDV P:SDV P:SDV
Oral double blind placebo
controlled food challenge
O:DBPCFC O:DBPCFC O:DBPCFC
(if passed at T2)
O:DBPCFC
(if passed at T2 and T3)
Skin prick test O:SPT O:SPT O:SPT O:SPT O:SPT O:SPT
Peanut allergen exposure
during breastfeeding
(maternal peanut consumption and
use of creams containing peanut oil)
P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M
Use of creams containing
peanut oil (on child)
P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Allergic reaction history – peanut P:PAQ P:SDV P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Trial phase Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 12 weeks)
T1
(1 day after final day of treatment)
T2
(12 weeks after final day of treatment)
Telephone Contact
(26 weeks after final day of treatment)
T3
(1 year after final day of treatment)
Month of study  up to -3 0 1-4 5-18 18 21 24 30
Week of study  up to -12 0 1-16 17-78 78 90 104 130
Randomisation X
(up to 1 week prior)
Oral immunotherapy (RUSH) X 1
Probiotic/placebo dispensed X X X
Oral immunotherapy/placebo
dispensed
X X X
Intervention compliance review
(every clinic visit during build up
and maintenance)
P:SDV P:SDV P:SDV
Diary review
(every clinic visit during build up
and  maintenance)
P:SDV P:SDV P:SDV
Adverse events and concomitant
medication review
(every clinic visit during build up
and maintenance)
P:SDV P:SDV P:SDV P:SDV P:SDV P:SDV
Oral double blind placebo
controlled food challenge
O:DBPCFC O:DBPCFC O:DBPCFC
(if passed DBPCFC at T1)
Skin prick test O:SPT O:SPT O:SPT O:SPT
Peanut allergen exposure
during breastfeeding
(maternal peanut consumption and
use of creams containing peanut oil)
P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M P:PAQ M
Use of creams containing
peanut oil (on child)
P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Allergic reaction history – peanut P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ

Featured measurements

DBPCFC: Double Blind Placebo Controlled Food Challenge
PAQ: PPOIT Allergy Questionnaires (various versions)
SDV: Study Devised Variable
SPT: Skin Prick Test

Notes

1 For RUSH protocol, please see:
PPOIT-1 – Tang, M.L., Ponsonby, A.-L., Orsini, F., Tey, D., Robinson, M., Su, E.L., Licciardi, P., Burks, W. and Donath, S. (2015). Administration of a probiotic with peanut oral immunotherapy: A randomized trial. J Allergy Clin Immunol. 135(3): 737-44.e8. doi: 10.1016/j.jaci.2014.11.034
PPOIT-2 – see ANZCTR website
PPOIT-3 – see ANZCTR website

Legend

A = Administration report abstraction
C = Index child report (reporting on others)
L = Linkage (to other databases)
M = Medical records data abstraction
O = Observation/direct assessment
N = Nurse report
P = Parent/primary caregiver report
Pe = Peer report
S = Self report
T = Teacher report
X = Undefined
XBF = Pertaining to biological father
XBM = Pertaining to biological mother
XC = Pertaining to index child
XF = Pertaining to father
XFam = Pertaining to family
XG = Pertaining to grandparent(s)
XM = Pertaining to mother
XP = Pertaining to parent(s)
XPa = Pertaining to partner
XPe = Pertaining to peers
XPr = Pertaining to primary caregiver
XSi = Pertaining to sibling(s)