Item1,10 | Screening | Baseline | Initial treatment | Maintenance treatment | ||
---|---|---|---|---|---|---|
Visit 0 | Visit 1 | Visit 2 | Visit 3 | Visit 4 | ||
Days −3 to 0 | Day 0 | Week 4 | Week 8 | Week 12 | ||
Basic demographics | X | |||||
Vital signs, physical examination | X | |||||
Allergies, medical history2, medication history3, surgical history4 | X | |||||
Smoking and drinking | X | |||||
Gastroscopy | X5 | X6 | ||||
Abdominal ultrasound B7 | X | |||||
Serum human chorionic gonadotropin (hCG) | X | |||||
ECG | X | X | ||||
Blood test, urine analysis, stool test (including occult blood) | X | X | ||||
Liver/kidney function8 | X | X | ||||
Signed informed consent | X | |||||
Inclusion/exclusion criteria verification | X | |||||
Primary outcome measure | GM11 (metagenomics) | X | X | X | X | |
Secondary outcome measures | RDQ | X | X | X | X | X |
GSRS | X | X | X | X | ||
Faecal metabolomics11 | X | X | X | X | ||
BMI 9 | X | X | X | X | ||
LA grade | X | X | ||||
Safety measures | AEs | X | X | X | ||
SAEs | X | X | X | |||
Compliance verification | X | X | X | |||
Concomitant medications | X | X | X | X |