Measure | Study period | Purpose | ||||
---|---|---|---|---|---|---|
Prior to intervention | Intervention | Follow-up (12 visits every 2 weeks) | ||||
Screening | Baseline | Colonoscopy visit | Every 2 weeks | Week 12 and week 24 visits | ||
Eligibility screening | X | Â | Â | Â | Â | Feasibility |
Informed consent | X | Â | Â | Â | Â | Feasibility |
Confirmation of eligibility | Â | X | Â | Â | Â | Feasibility |
Randomization | Â | X | Â | Â | Â | Feasibility |
Colonoscopy | Â | Â | X | Â | Â | Intervention |
Anthropometric measurements | Â | X | Â | X | Â | Covariates |
Food diary | Â | X | Â | Â | X | Covariates |
Mucosa biopsies/colon secretion | Â | Â | X | Â | Â | Microbial analysis |
Stool sample | Â | X | Â | Â | X | Microbial analysis |
Blood sample | Â | Â | X | Â | Â | Safety |
Concomitant medications | X | X | X | X | Â | Safety |
Symptoms diary | Â | Â | Â | X | Â | Safety/tolerance |
Toronto Side Effect Scale (TSES) | Â | X | Â | X | Â | Safety/efficacy |
Mini-International Neuropsychiatric Interview (MINI) | X | Â | Â | Â | Â | Feasibility |
Young Mania Rating Scale (YMRS) | X | X | Â | X | Â | Efficacy |
Montgomery–Asberg Depression Rating Scale (MADRS) | X | X |  | X |  | Efficacy |
State and Trait Anxiety Inventory (STAI) | Â | X | Â | X | Â | Efficacy |
Sheehan Disability Scale (SDS) | Â | X | Â | X | Â | Efficacy |
World Health Organization Quality of Life (WHOQOL-BREF) | Â | X | Â | X | Â | Efficacy |