Table 1.
Clinical studies on critically ill patients with Clostridium difficile infections.
| Ref. | Study Type | Patients | Intervention (Fecal Microbial Transplantation) | Controls | Outcomes | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||
| [43] | Open label randomized clinical trial | 56/0 | sCDI | 75 | 17M/39F | Lg-C | 1 × 28 pt, multiple 28 pt | U (71%), R (29%)/mostly fresh | x | ↓ AS, ↓ D | x/AS |
| [42] | Retrospective cohort study | 225 (50 pt FMT)/205 | fCDI, sCDI | 61.2 | 123M/102F | Lg-C (98%) | median of 2 FMT | U/Fresh (10%) and Frozen | ATB therapy | ↓ M | no comment |
| [33] | 17/15 | sCDI, cCDI | 66,4 | 18M/14F | no comments | average 1.83 ± 0.7 | ?/? | no more details | ↓ M | no comment | |
| [44] | 66/45 | sCDI, scCDI | 81 (69–87) | 23M/43F | Ug-NGS | 1 × 51 pt, 2 × 14 pt, 3 × 1 pt | R and U/Fresh (46%) and Frozen | Vanco p.o. +/– Metro i.v. or p.o. +/− FDX p.o. | ↓ M | x/AS, F | |
| [45] | 16/32 | sCDI, fCDI | 62,6 | 7M/9F | Lg-C,S | every 3–5 days until resolution | R and U/? | Vanco p.o. +/− Metro i.v. | ↓ M | 1 × bacteremia (6.3%), 1 × perforation (6.3%)/no comment | |
| [46] | Case series | 14/0 | sCDI, refCDI | 73.4 (52–92) | 5M/9F | Ug-Ngt (93%), Lg-C (7%) | 1 × 10 pt, 2 × 2 pt, 3 × 2 pt | R (85.7 %) and U/Fresh. | not applicable | ↓ AS, ↓ D | x/no comment |
| [47] | 75/0 | rCDI | 76.4 | 21M/54F | Lg-C (88%), Lg-S (9.3%) | no comments | R (13.5%) and U/? | ↓ AS, ↓ D | 3 pt post-procedural hypotension, one case of perforation. | ||
| [48] | 17/0 | sCDI, cCDI | 66.4 (38–89) | 4M/13F | Lg-C (94%), E,S Ug-Njt | 1 × 14 pt, 2 × 3 pt | R (58.8%) and U/? | ↓ AS, ↓ D | x/AS | ||
| [49] | 9/0 | sCDI, cCDI | 67.78 | 6M/3F | Ug-Njt (3×), Peg (1×) Lg-C (1×), Ug + Lg (C + Ngt) 4× | 1 × 8 pt, 2 × 1 pt | U and R/? | ↓ AS, ↓ D, ↓ Ilf, ↑ SA | x/no comment | ||
| [50] | 328/0//42 pt sCDI | sCDI, rCDI | 61.4 ± 19.3 | 87M/241F | Lg-C (76.9%) | no comments | ?/? | no comment | no comment | ||
| [51] | 64/0//26 pt sCDI | rCDI | 74 (29–94) | 25M/39F | Lg-C | 1 × 44 pt, multifecal infusion 20 pt | R (44%) and U/Fresh (83%) and Frozen | ↓ D | no comment | ||
| [52] | 94/0 | sCDI, fCDI + SOTp | 56,3 | 47M/47F | Ug-Njt, Lg-C (81%), E (17%), S, Caps. | no details | R and U/Fresh (41%) and Frozen | ↓ AS, ↓ D | 3.2% severe diarrhea, AKI, fever, CMV reactivation/22,3% AS,D | ||
| [29] | 80/0//36 pt sCDI, cCDI, refCDI | sCDI, refCD, recCDI + IC | 53 (20–88) | 42M/38F | Lg mostly | 1 × 62 pt, no more comments | ?/? | ↓ AS, ↓ D | aspiration, mucosal tear caused by the colonoscopy/15% any SAE (AS, IBD flare.) | ||
| [45] | 57/0 | sCDI, scCDI | 72 (60–79; 25–99) | 23M/34F | Lg-C | 1 × 30 pt, 2 × 16 pt, 3 × 4 pt, 4–5 × 2 pt | R and U/Fresh (51%) and Frozen | ↓ AS, ↓ D, ↑ SA | x/no comment | ||
| [53] | 146/0///s,cCDI 57(38.4%) | rCDI, sCDI, cCDI | 78.6 (65 to 97) | 46M/100F | Lg-C (80,8%), E,S Ug-Gfs, Ent | 1 × 130 pt, multiple 16 pt | ?/? | ↓ AS, ↓ D | x/D, AS 11 pt (7,5%) | ||
| [54] | 29/0 | sCDI, scCDI | 65,2 (25–92) | 12M/17F | Lg-C | 1 × 18 pt, 2 × 9 pt, 3 × 2 pt | R (36%) and U/? | ↓ D, ↑ SA | x/no comment | ||
| [55] | 35/0 | sCDI | 69 (29–91) | 17M/18F | Lg-C | 1 × 27 pt, multiple 8 pt | R (54%) and U/? | ↓ AS, ↓ D, ↑ SA | no comment | ||
| [56] | 4/0 | sCDI | 66–83 | 1M/3F | Lg-C | 1 × 2 pt, 2 × 2 pt | U/Fresh (25%) and Frozen | ↓ AS, ↓ D | no comment | ||
| [57] | Case report | 1/0 | sCDI | 65 | 1M | Ug-Njt | 1 × 1 pt | U/? | ↓ AS, ↓ D | x/no comment | |
| [58] | 1/0 | fCDI | 69 | 1M | LG-E | 1 × 1 pt | R/Fresh | ↓ AS, ↓ D, ↓ Ilf | x/no comment | ||
| [59] | 1/0 | fCDI | 26 | 1M | Lg-C | 2 × 1 pt | R/Fresh | ↓ AS, ↓ D, ↑ SA | x/no comment | ||
| [60] | 1/0 | sCDI | 75 | 1F | Ug-Njt | 1 × 1 pt | R/Fresh | ↓ D, ↓ Ilf | x/no comment | ||
| [61] | 1/0 | sCDI, rCDI | 65 | 1M | Lg-C | 1 × 1 pt | R/Fresh | x | SIRS 4 days subsequent to the FMT without detecting an infectious cause | ||
| [62] | 1/0 | fCDI + AML | 27 | 1M | Lg-S | 1 × 1 pt | U/Frozen | ↓ AS, ↓ D | x/no comment | ||
| [63] | 1/0 | CDI + HIV stage3 | 27 | 1M | Ug-Njt | 1 × 1 pt | R/Fresh | ↓ AS, ↓ D, ↓ Ilf | x/no comment | ||
| [38] | 1/0 | sCDI − liver Tx | 47 | 1W | Ug-caps, Lg-S | 2 × 1 pt | R/? | ↓ AS, ↓ D, ↓ Ilf | x/no comment | ||
| [64] | 1/0 | sCDI + SCTx | 21 | 1W | Ug-Njt | 1 × 1 pt | R/? | ↓ AS, ↓ D | x/no comment | ||
| [65] | 1/0 | fCDI + pBMcht | 56 | 1M | Ug- Njt, Lg-C | 11 × 1 pt (7 × C (days 2, 7, 8, 11, 12, 45, 48) + 4 × Njt (days 13, 14, 21, and 24) | U/Frozen | ↓ AS, ↓ D | x/no comment | ||
| [66] | 1/0 | sCDI | 71 | 1M | Lg-C | 1×1 pt | R/Fresh | ↓ AS, ↓ D | 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; sCDI, severe CDI; scCDI, severe complicated CDI; rCDI- recurrent CDI; fCDI, fulminant CDI; Vanco, vancomycin; Metro, metronidazole; FDX—fidaxomicin. SEX: F, female; M, male. Route of 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; Tx, transplantation.