Table 1 Samples of documented application of FMT in IBD clinical trials
Type of IBD | Study design/aim | Volume/frequency | Route | Observed outcome | References |
|---|---|---|---|---|---|
UC | Efficacy evaluation | 24 g/250 ml 20 g/100 ml 3 days | Nasojejunal tube Enema | 1/5 (20%) had clinical response with effective augmentation by FMT Side effects included temporal rise in C-reactive protein and fever | [31] |
UC | Prospective and uncontrolled study | 250 ml 5 rounds | Duodenal gastroscopy | Significantly reduced clinical index scores for diarrhea, abdominal pain, blood stool and intestinal mucosal lesions No serious adverse reactions | [32] |
CD with inflammatory mass | Efficacy and safety evaluation | Repeated every 3 months after initial dose | Mid-gut Transendoscopic enteral tubing | 68% (17/25) and 52% (13/25) clinical response and clinical remission at 3 months respectively At 6, 12 and 18 months, clinical remission were 48% (12/25), 32% (8/25) and 22.7% (5/22), respectively No severe adverse events | [33] |
UC | Pilot study on feasibility and safety | 165 ml/day 5 days | Enema | 7/9 (78%) had clinical response within 1 week 6/9 (67%) maintained clinical response at 1 month No serious adverse event | [34] |
UC | Randomized controlled trial | Days 1 and 21 | Nasoduodenal tube | 7/23 (30.4%) had clinical remission in intention-to-treat analysis 7/17 (41.2%) had clinical remission in the per-protocol analysis 2 patients had FMT-linked adverse events Responders had similar microbiota as that of donors by 12 weeks | [29] |
Fistulizing CD | A case study | 150 ml once | Mid-gut gastroscopy | Significantly alleviated fever, improved bloody purulent stool and decreased abdominal pain, with reduced intraperitoneal inflammatory mass at 1 week Clinical remission at 1 month Sustained clinical remission with resolved mass without exudation at 3 months | [35] |
Refractory CD | Pilot study on feasibility, efficacy and safety | Once | Mid-gut | 86.7% (26/30) and 76.7% (23/30) had clinical improvement and remission respectively at 1 month | [36] |
Mild to severe CD | Evaluation of efficacy in the short term and risk factors in the long term | 184 frequencies | Mid-gut | Clinical response and clinical remission were 45% (9/20) and 20% (4/20) in patients with adverse events, and 75.6% (90/119) and 63.0% (75/119) in patients without adverse events respectively Adverse events of 21.7% in manually prepared FMT and 8.7% in automated preparations Manual or automatic purification of fecal microbiota had no correlation with the efficacy of FMT | [37] |
UC | Randomised placebo-controlled trial | 5 days per week for 8 weeks | Colonoscopy Enemas | 11/41 (27%) who received FMT as against 3/40 (8%) who received placebo had steroid-free clinical remission with endoscopic remission or response Adverse events recorded in 32/41 (78%) FMT and 33/40 (83%) placebo patients with serious events in 2 FMT and 1 placebo patients | [38] |
CD | Prospective open-label study (uncontrolled) | Once | Colonoscopy | 58% (11/19) had clinical response Significant shift in fecal microbial diversity and composition toward donor’s profile Increased Treg cells (CD4+ CD25+ CD127lo) noticed in recipients’ lamina propria following FMT No serious adverse events recorded | [39] |