Table 2.
Differences in clinical safety markers after intervention
| Placebo (n = 12) | Faecal filtrate (n = 12) | p-value | ||
|---|---|---|---|---|
| # AEs (n (%)) | Total | 13 (44.8%) | 16 (55.2%) | – |
| Relatedness of AEs (n (%)) | Likely | 0 (0%) | 2 (12.5%) | 0.21 |
| Possibly | 2 (15.4%) | 6 (37.5%) | – | |
| Unlikely | 4 (30.8%) | 4 (25%) | – | |
| Not | 7 (53.9%) | 4 (25%) | – | |
| # Subjects with AE (n (%)) possibly or likely related | ≥1 AE | 2 (16.7%) | 6 (50%) | 0.19 |
| No AE | 10 (83.3%) | 6 (50%) | – | |
| Bilirubin (µmol/L) | Day 0 | 12 (6) | 15 (9) | 0.39 |
| Day 28 | 9 (5) | 12 (12) | – | |
| p-value | – | 0.030 | 0.16 | – |
| AF (U/L) | Day 0 | 76 (18) | 69 (16) | 0.17 |
| Day 28 | 79 (16) | 68 (16) | – | |
| GGT (U/L) | Day 0 | 22 (10) | 26 (11) | 0.30 |
| Day 28 | 22 (12) | 26 (9) | – | |
| ASAT (U/L) | Day 0 | 28 (8) | 28 (7) | 0.70 |
| Day 28 | 27 (8) | 25 (7) | – | |
| ALAT (U/L) | Day 0 | 29 (11) | 29 (10) | 0.85 |
| Day 28 | 28 (10) | 27 (9) | – | |
| Creatinine (µmol/L) | Day 0 | 85 (18) | 76 (15) | 0.20 |
| Day 28 | 82 (13) | 75 (15) | – | |
| eGFR (ml/min/1.73 m2) | Day 0 | 81 (12) | 86 (6) | 0.32 |
| Day 28 | 83 (9) | 85 (7) | – | |
| Urea (mmol/L) | Day 0 | 4.3 (0.9) | 4.4 (1.1) | 0.65 |
| Day 28 | 4.8 (0.9) | 5.1 (1.3) | – | |
| p-value | – | 0.047 | 0.012 | – |
| Haemoglobin (mmol/L) | Day 0 | 8.5 (1.0) | 8.8 (0.8) | 0.74 |
| Day 28 | 8.6 (0.9) | 8.6 (0.6) | – | |
| Haematocrit (L/L) | Day 0 | 0.41 (0.04) | 0.42 (0.03) | 0.84 |
| Day 28 | 0.42 (0.04) | 0.41 (0.03) | – | |
| MCV (fL) | Day 0 | 86.0 (4.7) | 88.0 (2.7) | 0.25 |
| Day 28 | 86.5 (4.5) | 88.1 (3.0) | – | |
| Thrombocytes (x109/L) | Day 0 | 265 (87) | 259 (45) | 0.85 |
| Day 28 | 263 (73) | 259 (48) | – | |
| Leucocytes (x109/L) | Day 0 | 6.2 (1.4) | 6.2 (1.2) | 0.56 |
| Day 28 | 5.8 (1.2) | 6.3 (1.4) | – | |
| Eosinophils (x109/L) | Day 0 | 0.15 (0.07) | 0.12 (0.06) | 0.61 |
| Day 28 | 0.16 (0.08) | 0.16 (0.11) | – | |
| Basophils (x109/L) | Day 0 | 0.04 (0.01) | 0.03 (0.02) | 0.27 |
| Day 28 | 0.04 (0.02) | 0.04 (0.02) | – | |
| Neutrophils (x109/L) | Day 0 | 3.64 (1.14) | 3.83 (0.97) | 0.36 |
| Day 28 | 3.25 (0.99) | 3.82 (1.13) | – | |
| Lymphocytes (x109/L) | Day 0 | 1.83 (0.40) | 1.70 (0.42) | 0.61 |
| Day 28 | 1.81 (0.29) | 1.77 (0.48) | – | |
| Monocytes (x109/L) | Day 0 | 0.48 (0.11) | 0.50 (0.10) | 0.60 |
| Day 28 | 0.47 (0.14) | 0.50 (0.08) | – | |
| Immunoglobulins (x109/L) | Day 0 | 0.02 (0.01) | 0.02 (0.01) | 0.31 |
| Day 28 | 0.02 (0.01) | 0.02 (0.01) | – |
Unless otherwise specified data are reported as mean (SD). Statistical testing for categorical variables of AE relatedness was done by Chi-square test and for the number of subjects with an AE Fisher’s exact test was used. Mixed model analyses were used to assess differences between groups and timepoints, whereafter post hoc analyses were performed with Bonferroni correction. All tests were two-sided. The p-values in the right column shows the overall effect of treatment on the variable and only when significant, the adjusted p-values from the post hoc tests are shown. The p-values underneath variables indicate statistically significant differences between days 0 and 28 within a treatment group. Source data are provided in the Source Data file.
AE adverse event, AF alkaline phosphatase, ALAT alanine aminotransferase, ASAT aspartate aminotransferase, eGFR estimated glomerular filtration rate, GGT gamma-glutamyl transferase, MCV mean corpuscular volume.