Table 1 Clinical treatment plan

Time

Day −15 –day 0

0 (visit 0)

Days 1–90 (visits 1–3) −3d to +3d

Visit 3

Day 129– day 135 (visit 5) −3d to +3d

Day 171– day 177 (visit 6) −3d to +3d

Informed consent

x

Demographics

X

Medical history concomitant medication

X

x

X

x

X

Physical exam, vital signs, weight

X

x

x

X

x

X

ECG

X

ECOG performance status and QOL assessment

X

x

x

X

x

X

Blood tests including pregnancy test

X

x

x

X

x

X

EGD with biopsies

x

X

x

X

Inclusion into study

Screening

Assignment to treatment group

Treatment phase

EOT

6 weeks after EOT

12 weeks after EOT = End of study

Time

Day −15–day 0

0 (visit 0)

Days 1–90 (visits 1–3) −3d to +3d

Visit 3

Day 129– day 135 (visit 5) −3d to +3d

Day 171– day 177 (visit 6) −3d to +3d

H. pylori serology

x

Stool samples

x

x

x

x

x

Rapid urease test

x

Assessment of neurocognitive function (NCT-A, CFF, VEP, EEG)

X

Days 1–28 weekly, then every 4 weeks

>x

x

x