Table 2 Outcomes and corresponding measures
Outcome | Measure |
|---|---|
Proportion of eligible patients who agree to take part in the study | % (95% CI) |
Ability to successfully recruit 60 patients within 6 months | % (95% CI) |
Proportion of participants adherent to prescribed study therapy (intervention or placebo) over the period of the study | % (95% CI) |
Proportion of patients who continue to the prebiotic supplementation | % (95% CI) |
Mean changes in the Gastrointestinal Symptom Rating Scale | Mean change (SD) |
Proportion of patients who withdraw from the PREBIOTIC study | % (95% CI) |
Proportion of participants providing two stool samples at designated times (the first week and between week 4 to week 6 post-kidney transplant) to assess gut microbiota changes | % (95% CI) |
Proportion of participants providing two blood samples at designated times (the first week and week 6 post-kidney transplant) | % (95% CI) |
Changes in the overall quality of life (measured by EQ-5D survey) | Mean change (SD) |
Proportion of patients with at least one infectious event | % (95% CI) |