TABLE 1.
References | Rossen et al. (17) | Moayyedi et al. (18) | Paramsothy et al. (19) | Costello et al. (20) | Haifer et al. (22) |
Crothers et al. (21) |
Number of patients | 48 (FMT: 23, placebo: 25) | 75 (FMT: 38, placebo: 37) | 81 (FMT: 41, placebo: 40) | 73 (FMT: 38, placebo: 35) | 35 (FMT: 15, placebo: 20) | 12 (FMT: 6, placebo: 6) |
Patient criteria | Mild-moderate (11 ≥ SCCAI ≥ 4, MES ≥ 1) | Mild-severe (Mayo: 4–12, MES ≥ 1) | Mild-moderate (Mayo: 4–10, MES ≥ 1/PGA ≤ 2) | Mild-moderate (Mayo: 3–10, MES ≥ 2) | Mild-moderate (Mayo: 4–10, MES ≥ 1) | Mayo: 4–10, MES ≥ 1, RBC ≥ 1, SFS ≥ 1 |
Pre-treatment | Bowel lavage | None | Bowel lavage | Bowel lavage | Amoxicillin, doxycycline, and metronidazole. | Ciprofloxacin, metronidazole, and bowel lavage |
Steroid | Concomitant (<10 mg) | Concomitant | Taper 2.5 mg/w to free | Taper 5 mg/w to free | Taper 2.5 mg/w to free | free |
FMT | 2 times | 6 times | 41 times | 3 times | 49 times | 85 times |
Donor | Single | Single | Multiple (3–7 donors) | Multiple (3–4 donors) | Single | Single |
Stool | Fresh | Fresh/frozen | Frozen −80°C | Frozen −80°C | Lyophilized | Frozen −20°C |
Primary endpoint (FMT vs. placebo) | CR + ER at week 12 30 vs. 20%, p = 0.51 |
CR + ER at week 7 24 vs. 5%, p = 0.03 |
CR + ER/Er at week 8 27 vs. 8%, p = 0.02 |
CR + ER at week 8 32 vs. 9%, p = 0.03 |
CR + ER/Er at week 8 53 vs. 15%, p = 0.027 |
CR at week 12 2/6 vs. 0/6, p = 0.45 |
Clinical remission (FMT vs. placebo) | 30 vs. 32%, p = 1.0 | 24 vs. 5%, p = 0.03 | 44 vs. 20%, p = 0.02 | 47 vs. 17%, p = 0.01 | 73 vs. 25%, p = 0.0045 | / |