Route |
Nasoduodenal |
Enema |
Colon (× 1) + enema (40) |
Colon (1) + enema (× 2) |
2 weeks Abx (Amox/metro/doxy) + oral lyophilized capsule |
Endpoint |
Week 12 |
Week 7 |
Week 8 |
Week 8 |
Week 8 |
Disease severity |
SCCAI 4–11, endoscopic subscore ≥ 1 |
Mayo ≥ 4, endoscopic subscore ≥ 1 |
Mayo 4–10 |
Mayo 3–10, endoscopic subscore ≥ 2 |
Mayo 4–10, endoscopic subscore ≥ 1 |
Primary outcome remission definition |
SCCAI ≤ 2, endoscopic Mayo improved by ≥ 1 |
Total Mayo ≤ 2, endoscopic Mayo = 0 |
Total Mayo ≤ 2, endoscopic Mayo improved by ≥ 1 point |
Total Mayo ≤ 2, endoscopic Mayo ≤ 1 |
Total Mayo ≤ 2, endoscopic Mayo improved by ≤ 1 point, steroid-free clinical remission |
Control |
Autologous |
Water |
Saline |
Autologous |
Placebo |
Volume |
120 ml |
50 ml |
150 ml |
200 ml + 100 ml |
Capsule 0.35 g lyophilized stool @ |
Timing |
Weeks 0 and 3 |
1/week |
5/weeks |
3 times |
Daily |
Duration |
3 weeks |
6 weeks |
8 weeks |
1 week |
8 weeks |
Number of FMTs |
2 |
6 |
41 |
3 |
24 capsules daily 1st week, 12 capsules daily 2nd week, 6 capsules daily 3rd to 8th weeks |
References |
[26] |
[25] |
[64] |
[14] |
[65] |