Protocol Activity | V1 (Screening) | V1.5 (Screening) | Washout period | V2 (Arm 1) | V3 (Arm 1) | V4 (Arm 1) | Washout period | V5 (Arm 2) | V6 (Arm 2) | V7 (Arm 2) |
---|---|---|---|---|---|---|---|---|---|---|
 | Week (−2) |  |  | Week 0 | Week 2 | Week 4 |  | Week 0 | Week 2 | Week 4 |
Informed consent process | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/Exclusion | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history & physical exam | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Vital signs | x | x | Â | x | x | x | Â | x | x | x |
Urine pregnancy test | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Standardized meals | x | x | Â | x | x | x | Â | x | x | Â |
Administer & review scales and questionnaires | Â | Â | Â | x | x | x | Â | x | x | x |
Review concomitant therapies | Â | x | Â | x | x | x | Â | x | x | x |
Intercurrent medical issues review | Â | x | Â | x | x | x | Â | x | x | x |
Randomization/study product preparation & dispensing | Â | Â | Â | x | x | Â | Â | x | x | Â |
Hydrogen breath test | Â | x | Â | x | x | x | Â | x | x | x |
Fecal collection | Â | Â | Â | x | x | x | Â | x | x | x |