Table 2.
Clinical studies on critically ill patients with inflammatory bowel diseases.
| Patient | Intervention (Fecal Microbial Transplantation) | Controls | Outcomes | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Type | N (FMT /Controls)//Critically Ill | Diagnosis | Age | Sex | Route of Administration | Frequency | Donor | No FMT Therapy | Beneficial | Adverse Events (Severe/Mild) | |
| R = Related, U = Unrelated, ? = Unknown; Fresh, Frozen, ? = Unknown | |||||||||||
| [73] | Double-blind placebo-controlled randomized trial | 38/37 | aUC | 42.2 (FMT)/35.8 (placebo) | 44M/31F | Lg-E | once weekly for 6 weeks | U/? | enema with placebo (water) | ↑ R | 1 pt in placebo gr urgent colectomy, 3 pt (1 pt in placebo gr 2 pt in FMT gr) rectal abscess, 1 pt in FMT gr CDI |
| [77] | Cohort study | 17/19 | mUC, sUC | 40.4 y (FMT), 44.8 y (ATB) | 13M/4F (FMT) 12M/7F (ATB) | Lg-C | 1 × 17 pt | U and R/Fresh | ATB therapy | ↓ AS | x/AS |
| [78] | 17/10 pt//5 pt sUC | refUC | 44 ± 18 (FMT), 36 ± 13 (ATB) | 14M/3F (FMT), 3M/7F (ATB) | Lg-C + S | 5× for 14 days (1 × C-4 × S) | U and R/Fresh | ATB therapy | ↓ AS, ↑ R | no comment | |
| [79] | 55/37//52 pt (56%) extensive colitis | refUC, mUC, sUC | 41.1 ± 13.9 | 56M/36F | Lg-C | 1 × 55 pt | U and R/Fresh | ATB therapy | ↓ AS | x/12 pt (13.0%) AS,D | |
| [79] | Case series | 30/0//20 pt (66.7 %) sIBD | refUC | 34.6 | 14M/16F | Lg-C | 1 × 27 pt, 2 × 3 pt | U (77%) and R/? | not applicable | ↓ AS, ↓ D, ↑ R | x/AS 7 pt (23.3%) |
| [80] | 14/0 | refIBD (8 UC, 6 CD) | 28–50 y | 7M/7F | Ug-Njt (64%), Lg-C, E | 2 × 5 pt, 4 × 9 pt (2 × Njt + 2 × C) | U (71%) and R/? | X (CD), ↑ R (UC) | 1 pt aspiration pneumonia/4 pt high fever | ||
| [81] | 14/0 | refUC | 47 ± 11 | no details | Lg-C | 1 × 5 pt, 2 × 1 pt, 4 × 3 pt, 6 × 2 pt | ?/? | ↓ AS | no comment | ||
| [82] | 6/0 | sUC, recUC | 25–53 | 3M, 3F | Lg-E | daily for 5 days | U/? | ↓ AS | no comment | ||
| [83] | 9/0//6 pt (66%) sUC | mUC, sUC | 47.90 (31–61) | 7M, 2F | Lg-C (55.6%), Ug-Njt (44.4%) | 3× (day 1, 3 and 5) | U/? | ↓ AS, ↑ R | x/AS 33.3% (3/9) | ||
| [71] | 30/0 | refCD | 38.0 ± 13.83 | 19M/11F | Ug-Njt | 1 × 30 pt | U and R/? | ↓ AS, ↑ R, ↑ BMI | x/F 2 pt | ||
| [84] | 12/0//7 pt (58.3%) sUC | mUC, sUC | 50.5 years (41–65) | M8/4F | Lg-C | multiple (no more comments) | U/? | ↓ AS, ↑ R | x/x | ||
| [85] | 67/0//15 pt (22.4%) sIBD | UC, CD + recCDI | 45.42 ± 17.33 | 28M, 39F | Lg-C,S | 1 × 60 pt, 2 × 6 pt, 3 × 1 pt | U/Fresh (88.1%) | ↓ AS, ↓ D | x/AS | ||
| [86] | 93/0 | refUC, mUC, sUC | 34.96 ± 11.27 | 58M/35F | Lg-C | 7× (week 0, 2, 6, 10, 14, 18, 22) | U/Fresh | ↓ AS | x/AS (30%) | ||
| [87] | 10/0//7 pt (70%) sUC | aUC | 31 (17–48) | 7M/3F | Lg-C | 1 × 10 pt | R/Fresh | x | x/6 pt exacerbation of the UC | ||
| [88] | 16/0 | aUC | 37 (18–66) | 10M, 6F | Ug-Gfs, Lg-C | 3× for 2–3 months | U/? | ↓ AS, ↓ Ilf, ↑ R | x/no comment | ||
| [89] | Case report | 1/0 | sUC | 19 | 1M | Lg-C,E | 3 × 1 pt | U/? | ↓ AS, ↑ R | x/no comment | |
Note: x, none; pt, patient; D, diarrhea; F, fever; AS, abdominal symptoms; SS, septic symptoms; R, remission; M, mortality; Ilf, inflammatory laboratory findings; SA, surgery avoiding; CDI, Clostridium difficile infection; Vanco, vancomycin; Metro, metronidazole; FDX, fidaxomicin. SEX: F, female; M, male; Route of FMT administration: Ug, upper GI; Lg, lower GI; Ngt, nasogastric tube; Ngi, nasogastric infusion; Njt, nasojejunal tube; Ent, enteroscopy; C, colonoscopy; S, sigmoidoscopy; E, enema; Caps, capsule. IBD, inflammatory bowel disease: a, active; s, severe, ref, refractory; gr, group.