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Table 1 Samples of documented application of FMT in IBD clinical trials

From: Mesenchymal stem cell–gut microbiota interaction in the repair of inflammatory bowel disease: an enhanced therapeutic effect

Type of IBDStudy design/aimVolume/frequencyRouteObserved outcomeReferences
UCEfficacy evaluation24 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]
UCProspective and uncontrolled study250 ml
5 rounds
Duodenal gastroscopySignificantly reduced clinical index scores for diarrhea, abdominal pain, blood stool and intestinal mucosal lesions
No serious adverse reactions
[32]
CD with inflammatory massEfficacy and safety evaluationRepeated every 3 months after initial doseMid-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]
UCPilot study on feasibility and safety165 ml/day
5 days
Enema7/9 (78%) had clinical response within 1 week
6/9 (67%) maintained clinical response at 1 month
No serious adverse event
[34]
UCRandomized controlled trialDays 1 and 21Nasoduodenal tube7/23 (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 CDA case study150 ml onceMid-gut gastroscopySignificantly 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 CDPilot study on feasibility, efficacy and safetyOnceMid-gut86.7% (26/30) and 76.7% (23/30) had clinical improvement and remission respectively at 1 month[36]
Mild to severe CDEvaluation of efficacy in the short term and risk factors in the long term184 frequenciesMid-gutClinical 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]
UCRandomised placebo-controlled trial5 days per week for 8 weeksColonoscopy
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]
CDProspective open-label study (uncontrolled)OnceColonoscopy58% (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]
  1. Summary of some of the IBD clinical trials on the feasibility, safety and efficacy of FMT. Different study designs across varying degrees and types of IBD employing distinct techniques, volumes and frequencies of FMT administration, yielded different patients’ responses
  2. CD Crohn’s disease, UC ulcerative colitis