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
Immunological measurements
(peanut specific IgE, IgG4 and IgA, peanut
specific Treg and DC populations, and
peanut induced cytokine responses)
X X
(week 17)
X
(first maintenance visit, week 49)
X X X X X
Stool sample analyses
(treatment compliance, presence of
LGG (probiotic bacteria), and Bifidobacterium spp)
– includes HITChip (Human Intestinal
Tract Chip) analysis
X X
(week 25)
X X X 1 X
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
Immunological measurements
(peanut specific serum IgE, IgG4)
planned planned planned planned planned
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
Immunological measurements
(peanut specific serum IgE, IgG4)
planned planned planned planned

Notes

1 PPOIT-1 – Stool sample collected at time of post treatment 3 phone interview, frozen and brought in at post treatment 4 clinic visit

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)